BioCentury
ARTICLE | Clinical News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

August 3, 2018 5:06 PM UTC

EMA's CHMP recommended a number of approvals July 26, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars.

The committee recommended approval of Onpattro to treat hereditary transthyretin (TTR)-mediated amyloidosis, which EMA is reviewing under accelerated assessment. The IV RNAi therapeutic targets the TTR gene using second-generation lipid nanoparticle (LNP) technology. It is also under Priority Review by FDA for the indication, with an Aug. 11 PDUFA date. Alnylam lost $2.04 to $104.51 July 27...