BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS® (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation. Alexion Pharmaceuticals Inc. (ALXN) has decided to pause further enrollment in the global phase III study of ULTOMIRIS … “While initial anecdotal reports from compassionate use cases were promising, these results demonstrate the importance of conducting controlled clinical trials to fully evaluate the potential of new treatment approaches and generate the necessary evidence to make informed decisions. This decision is based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis. INDICATIONS & IMPORTANT SAFETY INFORMATION for ULTOMIRIS® (ravulizumab-cwvz). ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. The trial will enroll adults with COVID-19 who are not hospitalized and aims to evaluate safety, to understand if the investigational treatment can reduce the duration of symptoms, and to test if the treatment can increase the proportion of participants with undetectable virus. Before you receive ULTOMIRIS, tell your doctor about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. The team, who started work on developing a vaccine to prevent COVID-19 on 20th January 2020 is led by Prof. Sarah Gilbert, Prof. Andrew Pollard, Prof. Teresa Lambe, Dr Sandy Douglas, Prof. Catherine Green and Prof. Adrian Hill. 21st April 2020. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. Your doctor will decide if you need additional vaccination. Alexion (ALXN) to Pause Enrollment in COVID-19 Study on Ultomiris. Phase 3 trial of Ultomiris in severe Covid-19 starts 22 April 2020 Pharmaceutical. For more information, ask your doctor or pharmacist. Alexion Pauses COVID-19 Trial Due To Lack of Efficacy. Oral COVID treatment yields promising trial data: drugmakers Colorized scanning electron micrograph of a dying cell (blue) heavily infected with SARS-CoV-2 (yellow), the virus that causes COVID … If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible. Article Affibody ends Alexion-partnered program. Forward-looking statements speak only as of the date they are made and cannot be relied upon as a guide to future performance. 1 - 7 of 7 Results. It is also approved in the U.S. and Japan for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients, as well as in the EU for the treatment of adults and children with a body weight of at least 10 kg with aHUS. Tell your doctor about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells. Alexion Pharmaceuticals to Initiate Phase 3 Study for Ultomiris as a Potential Coronavirus Treatment The trial will start in May and will enroll 270 patients with severe cases of COVID-19. It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. We are disappointed in this initial outcome, but plan to further analyze the data to identify potential subgroups who may benefit and to determine next steps. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly. The RECOVERY trial is evaluating a range of potential treatments for COVID-19 at 180 hospitals in the United Kingdom, Indonesia, and Nepal, and was designed with the … Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. In the UK, the TACTIC-R platform study led by Cambridge University Hospitals NHS Foundation Trust, which includes an ULTOMIRIS cohort, is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus, including reducing the need for ICU admission and ventilation. Alexion has said it can ramp up production if the drug works in trials but what it has not mentioned is its cost: Ultomiris is hugely expensive when used in rare diseases, costing several thousand dollars for a single vial and about $458,000 per year in aHUS when given as a maintenance therapy. Save as required by law or regulation, Alexion disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements in this press release that may occur due to any change in its expectations or to reflect events or circumstances after the date of this press release. There were no new safety findings observed. The trial will evaluate the drug in approximately 270 adults hospitalized with severe pneumonia or acute respiratory distress syndrome. This independent study remains ongoing. all rights reserved. Clinical trials use volunteers, who agree to participate in these types of studies. GlaxoSmithKline plans to apply for emergency use authorisation for an experimental Covid-19 treatment after initial clinical trial results showed an 85 per cent reduction in hospitalisation or death. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. If you have PNH and you stop receiving ULTOMIRIS, your doctor will need to monitor you closely for at least 16 weeks after you stop ULTOMIRIS. If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Call your doctor right away if you have any new signs or symptoms of infection. 13-12-2020. The Oxford Vaccine Centre’s COVID-19 vaccine trial is being run by the Jenner Institute and Oxford Vaccine Group. In the Phase III PEGASUS trial (NCT03500549), pegcetacoplan was better able to wean patients from regular blood transfusions versus Soliris, noted investigators who are all involved in the PEGASUS trial. COVID-19 Clinical Trials. https://www.clinicaltrialsarena.com/news/alexion-ultomiris-covid-19-trial Trials of an experimental drug that would fight the COVID-19 virus appear to show the medication prevents the virus from replicating in the body, making it the first oral antiviral to do so. “There is evidence that activation of the complement system is at least partially responsible for some of the organ damage we see in patients with COVID-19. Location. Alexion Announces Plans to Initiate Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19 No secondary endpoints were analyzed as part of the interim analysis. Search Filter Results. Coronavirus disease 2019 (Covid-19) has affected tens of millions of people globally 1 since it was declared a pandemic by the World Health Organization on March 11, 2020. Alexion Pharmaceuticals Inc. has decided to pause further enrollment in the global phase III study of ULTOMIRIS in adults with severe COVID-19 requiring mechanical ventilation as recommended by an independent data monitoring committee. Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated. We greatly value their contributions to help investigate potential ways to address this devastating pandemic,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. To be clear, Ultomiris is already registered and marketed in multiple nations for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, both rare diseases. Alexion Pharmaceuticals plans to initiate a global phase 3 clinical trial to evaluate Ultomiris (ravulizumab-cwvz) in hospitalized patients with severe COVID-19. We believe blocking this activation is a viable approach to investigate.” The trial is led and sponsored by Alexion Pharmaceuticals, which makes ravulizumab under the brand name Ultomiris. Before you can receive ULTOMIRIS, your doctor must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. SC Ultomiris’ approval is also likely, as topline Phase III data shows it is noninferior to its IV counterpart at day 71. More on this story. ULTOMIRIS is a prescription medicine used to treat: It is not known if ULTOMIRIS is safe and effective in children with PNH. Stopping ULTOMIRIS may cause breakdown of your red blood cells due to PNH. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. Washington University School of Medicine is one of 50 sites across four countries participating in this clinical trial… The study will continue for patients already enrolled, including completion of all study visits and planned ULTOMIRIS dosing according to the study protocol. ULTOMIRIS can cause serious side effects including infusion-related reactions. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Ultomiris was launched last year and is the follow-up drug to Soliris which is used to treat several rare diseases. Best … Phase 3 trial due to start in May. The Vitamin D and COVID-19 Trial (VIVID) is a nationwide randomized clinical trial in 2700 U.S. men and women to investigate whether taking a daily dietary supplement of vitamin D for 4 weeks reduces the risk of hospitalization and/or death in participants newly diagnosed with COVID-19, and reduces the risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in their closest … Alexion is to commence a phase 3 trial of Ultomiris in COVID-19 patients with severe pneumonia or acute respiratory distress syndrome, involving around 270 patients across the world. Pharma is pretty much throwing everything it has at COVID-19 and US rare disease firm Alexion has joined the fray, testing its Ultomiris in a subset of severely ill patients. Ultomiris is already approved for the rare diseases Atypical Haemolytic Uremic Syndrome (aHUS), and Paroxysmal Nocturnal Haemoglobinuria, which at first glance would seem a million miles away from a viral infection like COVID-19. Clinical trials are medical research studies to test new ways to prevent, detect, or treat diseases. Comments (0) Print. Locations: Clinical research sites … Alexion Pharmaceuticals has halted enrollment for its global phase 3 trial evaluating its monoclonal antibody Ultomiris (ravulizumab-cwvz) in adults with severe COVID-19 who require mechanical ventilation, after interim data showed the drug failed to show efficacy at 29 days post-treatment. – Independent data monitoring committee recommends pausing study enrollment due to lack of efficacy in pre-specified interim analysis –, – Company will conduct further analysis of trial data to determine next steps –, – No new safety findings were observed for ULTOMIRIS use in COVID-19 –. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache. You can also see nearby clinical trials by entering your ZIP code or city. You may report side effects to FDA at 1-800-FDA-1088. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. If you had a meningococcal vaccine in the past, you might need additional vaccination. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS. There are already ongoing or planned independent studies of Alexion’s complement inhibitors in patients with COVID-19. This follows a rapid review by the FDA of Alexion’s filing to begin clinical trials of Ultomiris for severe COVID-19. Chris Stevo, 857-338-9309 Alexion Pauses COVID-19 Trial Due To Lack of Efficacy. Meningococcal vaccines reduce but do not prevent all meningococcal infections. This press release may include statements that are or may be deemed to be forward-looking statements. The move, recommended by the trial's independent data monitoring committee, suggested Ultomiris may soon join the list of other therapeutics once tested against COVID-19 but now no longer. Symptoms or problems that can happen due to red blood cell breakdown include: drop in your red blood cell count, tiredness, blood in your urine, stomach-area (abdomen) pain, shortness of breath, blood clots, trouble swallowing, and erectile dysfunction (ED) in males. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. The IDMC recommended that additional enrollment be paused, pending further analysis of the data, due to lack of efficacy when ULTOMIRIS was added to best supportive care, compared to best supportive care alone. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "envisages", "plans", "projects", "anticipates", "targets", "aims", "expects", "intends", "may", "will" or "should" or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions and include, but are not limited to the plans of Alexion with respect to ULTOMIRIS as a potential treatment for severe COVID-19 patients. adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). Don't miss your daily pharmaphorum news. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. “We would like to thank the patients and their families, as well as investigators and healthcare professionals, who were essential to this study. Do not receive ULTOMIRIS if you have a meningococcal infection or have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. It will perform testing using nasopharyngeal swabs at specific time points. Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilis influenzae type b (Hib) if treated with ULTOMIRIS. Media COVID-19 Clinical Trials. ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Alexion (ALXN) decides to stop further enrollment in the late-stage study of Ultomiris in adults with severe COVID-19 requiring mechanical ventilation due to lack of efficacy. Clinical trials offer hope for many people and provide an opportunity to help researchers find new or improve existing treatments. This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever. 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Ultomiris is a longer lasting version of Alexion’s Soliris (eculizumab) complement inhibitor, which has produced “promising” evidence in the clinic through a compassionate use programme suggesting that this class of drugs may relieve injury to the lungs caused by the coronavirus. This means that it could be easier to administer in hospitals and could be manufactured at a higher capacity. Head of Investor Relations, Alexion Provides Update on Phase 3 Study of ULTOMIRIS® (ravulizumab) in Hospitalized Patients with Severe COVID-19, Prescribing Information and Medication Guide. This press release and further information about Alexion can be found at: www.alexion.com. SUBSCRIBE free here. Gilead has already faced criticism for what was seen as an attempt to cash in on the COVID-19 crisis with its potential therapy remdesivir, and Alexion will likely have similar issues to consider with Ultomiris if trials are successful. It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). The latter inhibits part of … pharmaphorum media limited. Article AstraZeneca forking out $39 billion to buy rare diseases firm. ULTOMIRIS is administered intravenously every eight weeks or, for pediatric patients less than 20 kg, every four weeks, following a loading dose. These forward-looking statements include all matters that are not historical facts and involve predictions. Welcome. 14-01-2021. Alexion pauses Phase III Ultomiris trial in COVID-19. ULTOMIRIS may also increase the risk of other types of serious infections. Ask your doctor if you are not sure if you need to be revaccinated. Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis. The study is expected to enrol about 270 patients across countries with high numbers of diagnosed cases, beginning in May. It will test the impact of Ultomiris on survival, duration of mechanical ventilation, and hospital stay compared with best supportive care. Find a Pfizer study that’s right for you by searching for conditions, keywords or a National Clinical Trials (NCT) number. – Company will conduct further analysis of trial data to determine next steps – – No new safety findings were observed for ULTOMIRIS use in COVID-19 – BOSTON, MA, USA I January 13, 2021 I Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS ® (ravulizumab-cwvz) in adults with severe COVID-19 requiring … Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally. A biologic medicine, Ultomiris (ravulizumab) works by inhibiting the complement system, which is thought to play a role in the severe pneumonia that can occur in patients with serious SARS-CoV-2 coronavirus infections. Alexion Pharma has joined the ranks of drugmakers trying to repurpose established drugs to treat coronavirus patients, saying it will start a phase 3 trial of its Ultomiris product next month. Tell your doctor about any side effect that bothers you or that does not go away. 15-06-2020. Any forward-looking statements reflect Alexion's current views with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to Alexion's results of operations, financial position, liquidity, prospects, growth or strategies and the industries in which they operate. C5 inhibition isn’t the answer to the search for treatments for severe Covid-19 after all. Economic, competitive, governmental, technological and other factors that may affect Alexion's operations are discussed in the section entitled "Risk Factors," Alexion's Quarterly Report on Form 10-Q for the Period ended 30 September 2020, as amended by any subsequent filings made with the SEC. ULTOMIRIS is approved in the United States (U.S.), European Union (EU) and Japan as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH). Massachusetts-based Alexion said it will begin a phase 3 study investigating UItomirus in COVID-19 patients hospitalised with severe pneumonia or acute respiratory distress syndrome (ARDS). adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. Alexion Provides Update on Phase 3 Study of ULTOMIRIS® (ravulizumab) in Hospitalized Patients with Severe COVID-19 Contacts Media Megan Goulart, 857 … Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Megan Goulart, 857-338-8634 The rights of trade mark owners are acknowledged. This follows a rapid review by the FDA of Alexion’s filing to begin clinical trials of Ultomiris for severe COVID-19. These are not all the possible side effects of ULTOMIRIS. Study Goal: This trial will assess whether LY-CoV555, a potential COVID-19 antibody treatment, can prevent SARS-CoV-2 infection among people at high risk of exposure due to residing or working in skilled nursing or assisted living facilities. Alexion will test rare disease drug Ultomiris in severe COVID-19. The IDMC’s recommendation was based on a pre-planned interim analysis of the primary endpoint – survival at Day 29 – once 122 patients completed the 29-day primary evaluation period. Website and content copyright © 2009-, pharmaphorum media limited or its licensors; ULTOMIRIS® (ravulizumab--cwvz) is the first and only long-acting C5 complement inhibitor. Conditions, Keywords or NCT Number. Alexion will test rare disease drug Ultomiris in severe COVID-19 Phase 3 trial due to start in May Alexion Pharma has joined the ranks of drugmakers trying to repurpose established drugs to treat coronavirus patients, saying it will start a phase 3 trial of its Ultomiris product next month. However, a potential approval spoiler for SC Ultomiris is its applicator, which may have … Executive Director, Corporate Communications, Investors What is the most important information I should know about ULTOMIRIS? Alexion said that outcomes reported to data support a controlled clinical programme with Ultomiris the preferred option of Soliris thanks to its less frequent, weight-based dosing schedule. In addition, we remain fully committed to our efforts to serve the rare disease community and to continuing to provide ULTOMIRIS to the patients who currently rely on it.”. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Forward-looking statements may and often do differ materially from actual results. But Alexion said the decision to press ahead with a late stage trial in coronavirus patients is based on preclinical data suggesting that inhibiting terminal complement can lower levels of chemical signals that drive inflammation associated with severe cases of the diseases. Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke. Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. What are the possible side effects of ULTOMIRIS? The disease, disorder, syndrome, illness, or injury that is being studied.
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