Alnylam’s Givlaari, Novo’s Rybelsus among CHMP’s latest recommendations

Among a series of recommendations issued Friday, EMA’s CHMP backed approval of what would be Alnylam’s second approved RNAi drug in the EU, as well as an oral diabetes therapy that Novo Nordisk is relying on to spur growth.

The committee’s recommendations included the approval of Givlaari givosiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) to treat acute hepatic porphyria in patients aged 12 and older. The EU approval would follow that of Alnylam’s Onpattro patisiran to treat polyneuropathy caused by hereditary TTR-mediated amyloidosis (hATTR); both are FDA-approved (see “Ambitions, Progress At R&D Day”)...