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Msg  34652 of 34657  at  8/5/2019 4:25:43 PM  by

Steve_382


Givosiran PDUFA date

 
 

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

− PDUFA Date Set for February 4, 2020 –

Alnylam Pharmaceuticals, Inc. (ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) in development for the treatment of acute hepatic porphyria (AHP), and granted Priority Review for the NDA. A Priority Review designation is granted to medicines that the FDA has determined have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease, and FDA’s goal is to take action within six months compared to 10 months under standard review.">Alnylam Pharmaceuticals, Inc. (ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) in development for the treatment of acute hepatic porphyria (AHP), and granted Priority Review for the NDA. A Priority Review designation is granted to medicines that the FDA has determined have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease, and FDA’s goal is to take action within six months compared to 10 months under standard review.

The FDA has set an action date of February 4, 2020 under the Prescription Drug User Fee Act (PDUFA), and the agency has indicated that they are not currently planning an advisory committee meeting as part of the NDA review.

Additionally, the Marketing Authorisation Application (MAA) for givosiran has been submitted to and validated by the European Medicines Agency (EMA). Givosiran was previously granted an accelerated assessment by the EMA, which is awarded to medicines deemed to be of major public health interest and therapeutic innovation, and is designed to bring new treatments to patients more quickly. Accelerated assessment potentially reduces the Agency’s evaluation time from 210 to 150 days.

Givosiran also previously received Breakthrough Therapy Designation from the FDA and Orphan Drug Designation in the U.S., as well as Priority Medicines (PRIME) Designation from the EMA and Orphan Drug Designation in the EU.

 


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Msg # Subject Author Recs Date Posted
34653 Re: Givosiran PDUFA date evernewbliss 0 8/5/2019 9:55:54 PM


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