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ARTICLE | Company News

CHMP backs therapies from Alexion, Novartis, Santhera

June 27, 2015 12:42 AM UTC

EMA's CHMP issued several recommendations on Friday, backing approval of MAAs for candidates from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Novartis AG (NYSE:NVS; SIX:NOVN) and Santhera Pharmaceuticals Holding AG (SIX:SANN).

CHMP recommended approval of Alexion's Strensiq asfotase alfa to treat bone manifestations of pediatric-onset hypophosphatasia. EMA is reviewing the compound under accelerated assessment. The fusion protein incorporating the catalytic domain of human tissue non-specific alkaline phosphatase ( TNSALP; ALPL) and a bone-targeting peptide is under Priority Review by FDA. CHMP recommended Strensiq's approval under EMA's exceptional circumstances clause; CHMP required that Alexion collect further efficacy and safety data. ...