The European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare are considering Alexion’s approval applications for Soliris and the NMOSD indication. Soliris was approved by the Australian Therapeutic Goods Administration for the treatment of PNH in February 2009. The FDA granted the approval of Soliris to Alexion Pharmaceuticals. The U.S. FDA approved Soliris (eculizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The US FDA has approved eculizumab (Soliris, Alexion) for the treatment of anti-aquaporin-4 antibody positive (AQP4-IgG-positive) neuromyelitis optica spectrum disorder (NMOSD), which accounts for nearly three-quarters of the population with NMOSD. This approval follows an expedited 6-month priority review from the agency. The FDA approval of SOLIRIS is … Uplizna is a CD19 monoclonal antibody and it is the first and only B-cell depleting therapy approved for NMOSD. Soliris also reduced the need for hospitalizations and the need for treatment of acute attacks with corticosteroids and plasma exchange. The drug maker, Alexion Pharmaceuticals, received FDA approval for the same indication in June. With the approval of Soliris, there is now for the first time an FDA-approved treatment available to NMOSD patients to help reduce the risk of relapse.” The approval was built on data from the Phase III PREVENT trial. “This approval changes the landscape of therapy for patients with NMOSD. Soliris ® (eculizumab) is approved by the FDA Soliris is used to treat adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). “This approval changes the landscape of therapy for patients with NMOSD. In June 2019, the FDA approved Soliris (eculizumab, Alexion Pharmaceuticals), the first therapy for the treatment of anti-aquaporin-4 (AQP4) autoantibody-positive NMOSD. In it, patients with NMOSD who tested anti-AQP4 antibody positive received Soliris or placebo. NMOSD mainly affects the optic nerves and spinal cord. Causes of PNH, aHUS, gMG and NMOSD. This approval follows an expedited 6-month priority review from the agency. With the approval of Soliris, there is now for the first time an FDA-approved treatment available to NMOSD patients to help reduce the risk of relapse.” The approval was built on data from the Phase III PREVENT trial. Several recent trials have supported the use of the drugs eculizumab (Soliris), satralizumab (Enspryng) and inebilizumab (Uplizna) in NMOSD, Pittock said, and all have received Food and Drug Administration approval to treat the condition over the past 2 years. It is an autoimmune disease of the CNS that mainly affects the optic nerves and spinal cord. Soliris helps treat your anti-AQP4 antibody-positive NMOSD, regardless of how many relapses you’ve had or when you were diagnosed. Summary of Uplizna and Enspryng In it, patients with NMOSD who tested anti-AQP4 antibody positive received Soliris or placebo. Binding of the anti-AQP4 antibody appears to activate other components of the immune system, causing inflammation and damage to the central nervous system. On September 23, 2011 the U.S. Food and Drug Administration (FDA) approved Eculizumab (Soliris®) for the treatment of all pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS)to inhibit complement mediated thrombotic microangiopathy . According to a press release, the FDA approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Soliris FDA Approval History. Treatment for neuromyelitis optica spectrum disorder (NMOSD) has transformed over the last year with FDA approvals for Alexion‘s Soliris and Viela … FDA Approved: Yes (First approved March 16, 2007) Brand name: Soliris Generic name: eculizumab Dosage form: Injection Company: Alexion Pharmaceuticals, Inc. This is the second indication for Soliris; it is already approved in the US and elsewhere in the world for rare blood condition paroxysmal nocturnal hemoglobinuria. Soliris ® (eculizumab) is the FIRST AND ONLY FDA-approved complement inhibitor indicated for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). First, the European Commission approved brand-name eculizumab (Soliris) for the treatment of adults with NMOSD who are anti-aquaporin-4 (AQP4) antibody positive. The drug is approved for use in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is a severe, rare autoimmune condition … “Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients’ lives,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. Soliris is given as an IV infusion in a health care setting at a wholesale average cost (WAC) of $700,000/year. “Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients’ lives,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. Most Read. LABline. Soliris was first approved by the FDA in 2007. "The FDA approval of Soliris is the beginning of a new era for these NMOSD patients as we continue on our mission to cure this life-threatening disease," Jackson added. What is NMOSD? Soliris was first approved by the FDA in 2007. 1. The drug is approved to reduce destruction of … The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body’s defence system called the ‘complement system’.. Officials with the FDA today approved eculizumab (Soliris, Alexion Pharmaceuticals) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease, in adults who are anti-aquaporin-4 (AQP4) antibody positive, according to a press release. Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome, Myasthenia Gravis. Prior to the FDA approved medications for AQP4 antibody positive NMOSD, treatments included rituximab, azathioprine, and mcyophenolate mofetil. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. FDA approves first treatment for NMOSD. The FDA on Thursday approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. 1. It is the first FDA-approved treatment for the autoimmune disease; the application priority review and the use for NMOSD received orphan drug designation. Soliris received FDA approval in June 2019 for the treatment of NMOSD with anti-aquaporin-4 (AQP4-IgG) positive antibodies. INDICATION: The FDA recently approved Soliris to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin 4 antibody-positive.NMOSD is a rare autoimmune disease affecting mainly the optic nerves and the spinal cord. Soliris also received FDA approval for the treatment of aHUS, gMG, and NMOSD. Alexion Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Soliris to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. The drug is also approved in the EU, Canada and Japan for the treatment of PNH, aHUS and gMG. “Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients’ lives,” said Billy Dunn MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. Alexion Pharmaceuticals has obtained approval to expand the use of Soliris to prevent relapse in anti-aquaporin-4 (AQP4) antibody-positive NMOSD. Pittock led the PREVENT trial of eculizumab, which showed a 94% reduction of relapse risk versus placebo. Image: The FDA has approved Alexion’s Soliris to treat adults with neuromyelitis optica spectrum disorder. NMOSD can be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). 4. “ We are thrilled to have partnered with industry to catalyze research and development of targeted therapies to treat NMOSD. In patients with PNH, aHUS, myasthenia gravis and NMOSD, the complement proteins are over-active and damage the patients’ own cells. Jul 1st, 2019. Individuals with NMOSD typically have eye pain and vision loss and can sometimes experience numbness, weakness, or paralysis of the arms and legs. 2. News. Officials with the FDA today approved eculizumab (Soliris, Alexion Pharmaceuticals) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease, in adults who are anti-aquaporin-4 (AQP4) antibody positive, according to a press release. “This approval changes the landscape of therapy for patients with NMOSD. WASHINGTON -- The first treatment for neuromyelitis optica spectrum disorder (NMOSD), a relapsing autoimmune inflammatory condition, received FDA approval Thursday. Eculizumab (Brand name: Soliris) - Manufactured by Alexion Pharmaceuticals, Inc FDA-approved indication: June 2019, eculizumab (Soliris) was approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. The FDA granted the approval of Soliris to Alexion Pharmaceuticals. The FDA approved the new indication on June 27, 2019.