The EMA's CHMP has recommended several new medicines for approval at its March 2016 meeting. The CHMP recommended granting a conditional MA for Darzalex (daratumumab) for the treatment of relapsed and refractory multiple myeloma. Darzalex has an orphan designation and was reviewed under EMA's accelerated assessment scheme. The CHMP also recommended granting an MA for orphan-designated Galafold (migalastat) for the treatment of Fabry disease, a rare genetic disorder. Pandemic influenza vaccine H5N1 MedImmune also received a positive opinion from the CHMP, together with a biosimilar monoclonal antibody, Flixabi (infliximab), for the treatment of rheumatoid arthritis, adult and pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis; Neparvis (sacubitril/valsartan) for the treatment of chronic heart failure with reduced ejection fraction; and Palonosetron Accord (palonosetron) for the prevention of nausea and vomiting associated with chemotherapy.
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