Biogen, Alkermes get approval for Vumerity in USA, to treat relapsing forms of MS

Biogen and Alkermes got approval from USFDA for Vumertiy, a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

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European Commission approves Dupixent for severe chronic rhinosinusitis with nasal polyposis

European Commission has approved a third indication for Dupixent® (dupilumab) for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. It is also approved for moderate-to-severe atopic dermatitis and severe asthma.

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FDA splits proposed indications for Blueprint Medicines’ avapritinib into two separate NDAs

Blueprint Medicines Corporation said in an update on its New Drug Application (NDA) for avapritinib for the treatment of adults with PDGFRA , that the FDA has said it plans to administratively split the proposed indications for avapritinib into two separate NDAs, one for PDGFRA Exon 18 mutant GIST, regardless of prior therapy, and one for fourth-line GIST.

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