US FDA Accepts Alexion's sBLA Filing of Soliris as for Refractory Generalised Myasthenia Gravis.
M2 PHARMA-March 9, 2017-US FDA Accepts Alexion's sBLA Filing of Soliris as for Refractory Generalised Myasthenia Gravis
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- The US Food and Drug Administration has accepted for review US-based biopharmaceutical company Alexion Pharmaceuticals, Inc.'s (NASDAQ: ALXN) supplemental Biologics License Application to extend the indication for Soliris (eculizumab) as a potential treatment for patients with refractory generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive, the company said.
The sBLA submission is supported by comprehensive data from the Phase 3 REGAIN study. The FDA set a Prescription Drug User Fee Act (PDUFA) date of 23 October 2017.
If approved, Soliris would be the first and only complement inhibitor for patients with refractory AChR-positive gMG. Soliris has received Orphan Drug Designation for the treatment of patients with MG in the US and EU. Soliris is not approved in any country for the treatment of patients with refractory AChR-positive gMG.
Refractory generalized myasthenia gravis patients who are anti-acetylcholine receptor antibody-positive represent an ultra-rare segment of patients with MG, a chronic, debilitating and progressive autoimmune neuromuscular disease where the complement system mediates a progressive, destructive inflammatory effect on the neuromuscular junction.
Patients with refractory AChR-positive gMG experience severe morbidities despite currently available MG therapies.
Soliris is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialisation by Alexion.
It is approved in the US, European Union, Japan and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis.
PNH is a debilitating, ultra-rare and life-threatening blood disorder, characterized by complement-mediated hemolysis (destruction of red blood cells).
Soliris is also approved in the US, European Union, Japan and other countries as the first and only treatment for patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy, or TMA (blood clots in small vessels).
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|Date:||Mar 9, 2017|
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