Research & Development
US FDA accepts Eiger BioPharmaceuticals' New Drug Application for accelerated Zokinvy review
20 May 2020 -

The United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) from US based Eiger BioPharmaceuticals Inc (Nasdaq:EIGR) for accelerated review of Zokinvy (lonafarnib) intended for the treatment of Progeria and Progeroid Laminopathies, it was reported on Tuesday.

The US FDA has granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of 20 November 2020. Zokinvy for treatment of Progeria and Progeroid Laminopathies, an ultra-rare and fatal genetic condition of accelerated aging in children, has been granted Rare Paediatric Disease Designation.

'The acceptance of our first NDA is a significant milestone for Eiger, and an important step toward bringing a treatment to children and young adults with Progeria and Progeroid Laminopathies,' said David Cory, President and CEO of Eiger. 'We would like to thank The Progeria Research Foundation (PRF) for their commitment, persistence and dedication. Most importantly, we are grateful to all the children with Progeria and their families who have made this possible by participating in the lonafarnib clinical trials. We are preparing for the commercial launch of Zokinvy in the US and Europe.'

Leslie Gordon, MD, PhD, PRF medical director, said, 'This milestone is the culmination of twelve years of clinical trials, treating children from over 30 countries and six continents with Progeria and Progeroid Laminopathies. We are fortunate to have Eiger as a partner for the preparation and filing of the NDA and providing continuous Zokinvy (lonafarnib) drug supply to children and young adults with Progeria. We are grateful to all the children with Progeria and their families. Their courage inspires all of us, every day.'

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