FDA accepts Zokinvy for accelerated review in treatment of Progeria and Progeroid Laminopathies

20 May 2020

The US Food and Drug Administration has accepted the New Drug Application (NDA) for accelerated review of Zokinvy (lonafarnib) in the treatment of Progeria and Progeroid Laminopathies, submitted by USA-based rare diseases specialist Eiger BioPharmaceuticals (Nasdaq: EIGR), sending the firm’s shares up 2% in after-hours trading on Tuesday.

The FDA granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of November 20, 2020. The FDA is not currently planning to hold an advisory committee meeting to discuss this application.

Zokinvy is the subject of a licensing deal with US pharma giant Merck & Co (NYSE: MRK).

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