Alnylam not to seek accelerated approval of givosiran

16 October 2018

Shares of RNAi therapeutics company Alnylam Pharmaceuticals (Nasdaq: ALNY) fell 2.37% to $80.01 by close of trading on Monday, after the company revealed that it would not aim for accelerated approval of givosiran.

Instead, in consultation with the US Food and Drug Administration, the company plans to pursue a full approval based on the complete results of the ENVISION Phase III study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyria (AHP), rather than filing based on the interim Phase III results.

The FDA has also agreed to a rolling submission of a New Drug Application (NDA), which will be initiated in 2018 with full clinical sections submitted in mid-2019, assuming positive study results.

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