The following slide deck was published by Alexion Pharmaceuticals, Inc. ULTOMIRIS is administered intravenously every eight weeks or, for pediatric patients less than 20 kg, every four weeks, following a loading dose. Before you receive SOLIRIS, 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. BOSTON--(BUSINESS WIRE)--May 14, 2020-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that five abstracts have been accepted for presentation at the 25th Congress of the European Hematology Association (EHA), which … It is not known if ULTOMIRIS or SOLIRIS will harm an unborn baby or if these medicines pass into the breast milk. For patients with PNH, the doctor will need to monitor the patient closely for at least 16 weeks after stopping ULTOMIRIS or 8 weeks after stopping SOLIRIS. Meningococcal vaccines reduce but do not prevent all meningococcal infections. For more information, ask your doctor or pharmacist. Learn about product indications and Important Safety Information. ULTOMIRIS and SOLIRIS can affect how other medicines work, causing side effects. Call your doctor right away if you miss an ULTOMIRIS or SOLIRIS infusion or for medical advice about side effects. The accepted abstracts are listed below and are now available on the ASH website: Paroxysmal Nocturnal Hemoglobinuria (PNH) Abstracts. This website is intended only for residents of the United States. Abstract ID #2575 – poster presentation, Dec. 7, 2020, 7:00 a.m. – 3:30 p.m. Pacific Time. The most devastating consequence of chronic hemolysis is the formation of blood clots, which can occur in blood vessels throughout the body, damage vital organs, and potentially lead to premature death. If the patient has not been vaccinated and therapy must be initiated immediately, two weeks of antibiotics should also be administered with the vaccinations. Available tests can help distinguish aHUS from other hemolytic diseases with similar symptoms. The prognosis of aHUS can be poor in many cases, so a timely and accurate diagnosis—in addition to treatment—is critical to improving patient outcomes. 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. It is not known if ULTOMIRIS is safe and effective in children with PNH or in children younger than one month of age in aHUS. Meningococcal vaccines must be received at least two weeks before the first dose of ULTOMIRIS or SOLIRIS if the patient has not already had this vaccine. ULTOMIRIS is a prescription medicine used to treat: It is not known if ULTOMIRIS is safe and effective in children with PNH. ULTOMIRIS can cause serious side effects including infusion reactions. 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. You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Please see the accompanying full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections. The following slide deck was published by Alexion Pharmaceuticals, Inc. Working at Alexion is an experience like no other. Call your doctor for medical advice about side effects. e-poster presentation, abstract ID#: EP862. Patients should tell their doctor or nurse right away if they get any of these symptoms during the SOLIRIS infusion: chest pain, trouble breathing or shortness of breath, swelling of the face, tongue, or throat, and feeling 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. “ULTOMIRIS is an important new standard of care for patients with PNH and atypical hemolytic uremic syndrome,” said John Orloff, M.D., Executive Vice President and Head of Research and Development at Alexion. View Presentation 3.3 MB. Available tests can help distinguish aHUS from other hemolytic diseases with similar symptoms. Average salaries for Alexion Pharmaceuticals Presentation Specialist: $70,601. The most devastating consequence of chronic hemolysis is the formation of blood clots, which can occur in blood vessels throughout the body, damage vital organs, and potentially lead to premature death. Visit MedWatch, or call 1-800-FDA-1088. e-poster presentation, abstract ID#: EP866. SOLIRIS is only available through a program called the SOLIRIS REMS. This card must be carried at all times during treatment and for 8 months after the last ULTOMIRIS dose or 3 months after the last SOLIRIS dose. To learn more about the regulatory status of SOLIRIS in the countries that we serve, please visit www.alexion.com. + Represent epidemiology department in cross-functional team meetings with presentation of summary findings to Alexion senior management and/or external stakeholders. Neither ULTOMIRIS nor SOLIRIS is for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Accepted data include a new analysis from two Phase 3 extension studies that demonstrate similar safety and consistent and durable efficacy of ULTOMIRIS® (ravulizumab-cwvz) through 52 weeks when used to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who are greater than 65 years old compared to those who are 65 years old or younger. 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. The most common side effects in people with gMG treated with SOLIRIS include: muscle and joint (musculoskeletal) pain. We look forward to the opportunity to present these data during the virtually-held EHA meeting.”. Paroxysmal nocturnal hemoglobinuria (PNH) is a serious ultra-rare blood disorder with devastating consequences. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. About Paroxysmal Nocturnal Hemoglobinuria (PNH) PNH occurs when the complement system—a part of the body’s immune system—over-responds, leading the body to attack its own red blood cells. 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 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). Development of A Composite Endpoint to Evaluate Treatment Benefit in Patients with Paroxysmal Nocturnal Hemoglobinuria. In addition, SOLIRIS is used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. An application is also under review with the European Medicines Agency. Initiation of a Phase 1 study in adults with HPP is planned for the second quarter of 2021. 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 is administered intravenously every eight weeks or every four weeks for pediatric patients less than 20 kg, following a loading dose. The most common side effects in people with aHUS treated with SOLIRIS include: headache, diarrhea, high blood pressure (hypertension), common cold (upper respiratory infection), stomach-area (abdominal) pain, vomiting, pain or swelling of your nose or throat (nasopharyngitis), low red blood cell count (anemia), cough, swelling of legs or feet (peripheral edema), nausea, urinary tract infections, and fever. Abstract ID #1579– poster presentation, Dec. 5, 2020, 7:00 a.m. – 3:30 p.m. Pacific Time. Before a patient can receive ULTOMIRIS or SOLIRIS, their doctor must: enroll in the corresponding ULTOMIRIS REMS or SOLIRIS REMS program; counsel the patient about the risk of meningococcal infection; give the patient information and a Patient Safety Card about the symptoms and risk of meningococcal infection (as discussed above); and make sure that the patient is vaccinated with a meningococcal vaccine. In addition, an observational analysis of U.S. claims databases will be presented, highlighting the complexity of identifying patients with atypical hemolytic uremic syndrome (aHUS). As the global leader in complement biology and inhibition for more than 20 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). SOLIRIS® (eculizumab) is a first-in-class C5 complement inhibitor. Atypical Hemolytic Uremic Syndrome (aHUS) Abstracts. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. About Paroxysmal Nocturnal Hemoglobinuria (PNH). adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). Please refer to the full U.S. Prescribing Information and Medication Guide for ULTOMIRIS and SOLIRIS available via the links below, including the BOXED WARNING regarding serious and life-threatening meningococcal infections for both medicines. ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). To learn more about the regulatory status of SOLIRIS in the countries that we serve, please visit www.alexion.com. © 2021 Alexion Pharmaceuticals, Inc. https://www.businesswire.com/news/home/20200514005533/en/. aHUS occurs when the complement system—a part of the body’s immune system—over-responds, leading the body to attack its own healthy cells. Patients should ask their doctor if an additional meningococcal vaccination is needed. Meningococcal vaccines reduce but do not prevent all meningococcal infections. Both medicines increase the chance of getting serious and life-threatening meningococcal infections. View source version on businesswire.com: https://www.businesswire.com/news/home/20200514005533/en/, Alexion: Media Megan Goulart, 857-338-8634 With a focus on rare diseases that have few, if any, effective treatments, each endeavor is urgent and every day counts. - Accepted abstracts include interim Phase 2 extension data demonstrating reduced duration of infusion with ULTOMIRIS® (ravulizumab-cwvz) 100 mg/mL formulation -, - Data from five abstracts demonstrate Alexion’s continued commitment to advancing the understanding of PNH with ongoing real-world studies and emerging clinical data -. 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. The following slide deck was published by Alexion Pharmaceuticals, Inc. ... Earnings Call Presentation. SOLIRIS is administered intravenously every two weeks, following an introductory dosing period. ULTOMIRIS® (ravulizumab-cwvz) is the first and only long-acting C5 complement inhibitor. It is not known if SOLIRIS will harm your unborn baby or if it passes into your breast milk. For more information, ask your doctor or pharmacist. ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Groundbreaking innovation and life-saving therapies, driven by a team with a shared sense of purpose and dedication — that’s Alexion. 4, 2021– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that three abstracts have been accepted for presentation at the 73 rd annual meeting of the American Academy of Neurology (AAN), taking place virtually from April 17 through April 22, 2021.New real-world data will be presented evaluating SOLIRIS ® (eculizumab) for the … The Investor Relations website contains information about Alexion Pharmaceuticals, Inc.'s … Total revenues for the full year of 2019 were $4,991.1 million , a 21 percent increase compared to 2018. You may report side effects to FDA at 1-800-FDA-1088. PNH often goes unrecognized, with delays in diagnosis from one to more than five years. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. It is important that you have all recommended vaccinations before you start SOLIRIS, receive 2 weeks of antibiotics if you immediately start SOLIRIS, and stay up-to-date with all recommended vaccinations during treatment with SOLIRIS. The doctor will provide a Patient Safety Card about the risk of meningococcal infection. ULTOMIRIS may also increase the risk of other types of serious infections. aHUS affects both adults and children, and many patients present in critical condition, often requiring supportive care, including dialysis, in an intensive care unit. This press release and further information about Alexion can be found at: www.alexion.com. If you have PNH, your doctor will need to monitor you closely for at least 8 weeks after stopping SOLIRIS. INDICATIONS & IMPORTANT SAFETY INFORMATION FOR SOLIRIS® (eculizumab). During the meeting, results will be presented from an interim analysis of the Phase 2 ULTOMIRIS® (ravulizumab-cwvz) 100 mg/mL formulation open-label study extension period. Tell your doctor about any side effect that bothers you or that does not go away. + Maintain awareness of epidemiology with respect to regulatory requirements, payer trends, and advancement of pharmacoepidemiology methods. 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. The U.S. Food and Drug Administration (FDA) is currently reviewing the company’s supplemental biologics application for the ULTOMIRIS 100mg/mL formulation for the treatment of atypical hemolytic uremic syndrome (aHUS) and for adults with PNH. Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. aHUS is an ultra-rare disease that can cause progressive injury to vital organs, primarily the kidneys, via damage to the walls of blood vessels and blood clots. The most common side effects in people with NMOSD treated with SOLIRIS include: common cold (upper respiratory infection), pain or swelling of your nose or throat (nasopharyngitis), diarrhea, back pain, dizziness, flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches, join pain (arthralgia), throat irritation (pharyngitis), and bruising (contusion). The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of October 11, 2020. This would reduce the time patients spend receiving their infusion—in clinic or in-home settings—lessening the overall burden on healthcare systems. Q4 Earnings Presentation 3.3 MB. + Excellent communication and presentation skills. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells.
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