alexion pharmaceuticals presentation
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. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Your doctor will decide if you need additional vaccination. e-poster presentation, abstract ID#: EP862. Meningococcal vaccines reduce but do not prevent all meningococcal infections. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. All e-poster presentations will be available on the EHA website for the duration of the Congress. The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever. ULTOMIRIS can cause serious side effects including infusion-related reactions. ULTOMIRIS and SOLIRIS can affect how other medicines work, causing side effects. aHUS can cause sudden organ failure or a slow loss of function over time—potentially resulting in the need for a transplant, and in some cases, death. 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 and cardiology. Patients with PNH may experience a range of symptoms, such as fatigue, difficulty swallowing, shortness of breath, abdominal pain, erectile dysfunction, dark-colored urine and anemia. Apply on company website Save. 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). 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. About ULTOMIRIS® (ravulizumab‑cwvz) “An interim analysis of a PNH study evaluating the higher concentration formulation showed a 78-minute reduction in infusion time for adult patients in the 60-100kg cohort (representative of the majority of patients treated for PNH), and comparable safety, pharmacokinetics, and immunogenicity to the current formulation. 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). An Interim Analysis of A Phase 2 Study Evaluating The Efficacy, Safety, and Pharmacokinetics of Intravenous Ravulizumab 100 mg/mL Formulation in Patients with Paroxysmal Nocturnal Hemoglobinuria. The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache. 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 will be held virtually from June 11 to 14, 2020. aHUS affects both adults and children, and many patients present in critical condition, often requiring supportive care, including dialysis, in an intensive care unit. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. BOSTON--(BUSINESS WIRE)--Mar. Certain fungal infections (Aspergillus) may occur if you take SOLIRIS and have a weak immune system or a low white blood cell count. patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). The most common side effects in people with gMG treated with SOLIRIS include: muscle and joint (musculoskeletal) pain. Before a patient receives ULTOMIRIS or SOLIRIS, they should tell their doctor about all of their medical conditions, including if they: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. Tell your doctor about any side effect that bothers you or that does not go away. ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. INDICATIONS & IMPORTANT SAFETY INFORMATION for ULTOMIRIS® (ravulizumab-cwvz). - 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 -. This website is intended only for residents of the United States. PNH can strike men and women of all races, backgrounds and ages without warning, with an average age of onset in the early 30s. It is characterized by the destruction of red blood cells, which is also referred to as hemolysis. Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that 11 abstracts will be presented at MSVirtual2020, the 8th joint Americas Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS) meeting, taking place virtually from September 11 to 13, 2020. Senior Director, Corporate Communications, Investors Chris Stevo, 857-338-9309 Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Alexion embraces the communities in which we operate. Additional data being presented at the meeting include analyses from the ongoing, observational real-world study of SOLIRIS® (eculizumab) as a treatment for PNH, along with a study evaluating the use of ALXN2040 (danicopan, formerly ACH-4471)—an investigational, oral, factor D inhibitor—used as an add-on therapy for the small, subgroup of PNH patients who are also diagnosed with extravascular hemolysis. ULTOMIRIS is approved in the United States (U.S.), European Union (EU) and Japan as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH) and in the U.S. for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric (one month of age and older) patients. + Excellent communication and presentation skills. Available tests can help distinguish aHUS from other hemolytic diseases with similar symptoms. Ask your doctor if you are not sure if you need to be revaccinated. Head of Investor Relations, We use cookies to give you the best online experience. If you have PNH, your doctor will need to monitor you closely for at least 8 weeks after stopping SOLIRIS. e-poster presentation, abstract ID#: EP853. These are not all the possible side effects of SOLIRIS. 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. BOSTON –(BUSINESS WIRE)–Mar. SOLIRIS is only available through a program called the SOLIRIS REMS. In many countries around the world, SOLIRIS is approved to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), adults with generalized myasthenia gravis (gMG) who are acetylcholine receptor (AchR) antibody positive and/or adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. BOSTON--(BUSINESS WIRE)--Jan. 30, 2020-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the fourth quarter and full year of 2019. IMPORTANT SAFETY INFORMATION Call your doctor right away if you miss an ULTOMIRIS or SOLIRIS infusion or for medical advice about side effects. PNH is a serious ultra-rare blood disorder with devastating consequences. 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. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. © 2021 Alexion Pharmaceuticals, Inc. https://www.businesswire.com/news/home/20200514005533/en/. “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. About Paroxysmal Nocturnal Hemoglobinuria (PNH) SOLIRIS can cause serious side effects including serious allergic reactions. Symptoms or problems that can happen due to red blood cell breakdown include: a drop in red blood cell count, tiredness, blood in the urine, stomach-area (abdomen) pain, shortness of breath, blood clots, trouble swallowing, and erectile dysfunction (ED) in males. 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. Abstract ID #1686 – poster presentation, Dec. 6, 2020, 7:00 a.m. – 3:30 p.m. Pacific Time. May 5, 2020 at 8:00 AM EDT The most common side effects in people with NMOSD treated with SOLIRIS include: common cold (upper respiratory infection); pain or swelling of the nose or throat (nasopharyngitis); diarrhea; back pain; dizziness; flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches; joint pain (arthralgia); throat irritation (pharyngitis), and bruising (contusion). New data will also be presented that show the safety and efficacy of ULTOMIRIS when used concomitantly with immunosuppressive therapy (IST) in patients with PNH. Stopping treatment with these medicines may cause breakdown of the red blood cells due to PNH. Certain people may be at risk of serious infections with gonorrhea. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible. PNH often goes unrecognized, with delays in diagnosis from one to more than five years. The following slide deck was published by Alexion Pharmaceuticals, Inc. aHUS can cause sudden organ failure or a slow loss of function over time—potentially resulting in the need for a transplant, and in some cases, death. 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. Forward-Looking Statement 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. 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. It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. The prognosis for patients with aHUS can be poor in many cases, so a timely and accurate diagnosis—in addition to treatment—is critical to improving patient outcomes. ULTOMIRIS is administered intravenously every eight weeks or every four weeks for pediatric patients less than 20 kg, following a loading dose. 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. Abstract ID #2586 – poster presentation, Dec. 7, 2020, 7:00 a.m. – 3:30 p.m. Pacific Time. 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. Abstract ID #2575 – poster presentation, Dec. 7, 2020, 7:00 a.m. – 3:30 p.m. Pacific Time. To learn more about the regulatory status of ULTOMIRIS in the countries that we serve, please visit www.alexion.com. What are the possible side effects of SOLIRIS? 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. Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if treated with SOLIRIS. Symptoms or problems that can happen due to red blood cell breakdown include: drop in the number of your red blood cell count, drop in your platelet count, confusion, kidney problems, blood clots, difficulty breathing, and chest pain. adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). SOLIRIS® (eculizumab) is a first-in-class C5 complement inhibitor. Total revenues for the full year of 2019 were $4,991.1 million , a 21 percent increase compared to 2018. 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. In many countries around the world, SOLIRIS is approved to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), adults with generalized myasthenia gravis (gMG) who are acetylcholine receptor (AchR) antibody positive and/or adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. e-poster presentation, abstract ID#: EP845.