Eiger BioPharmaceuticals Reports the US FDA’s Acceptance of NDA for Zokinvy (lonafarnib) to Treat Progeria and Progeroid Laminopathies

Eiger BioPharmaceuticals Reports the US FDA’s Acceptance of NDA for Zokinvy (lonafarnib) to Treat Progeria and Progeroid Laminopathies

Shots:

  • The US FDA has accepted the NDA for accelerated review of Zokinvy (lonafarnib) and has granted PR designation with the anticipated PDUFA date as Nov 20, 2020. The US FDA is not planning to hold an advisory committee meeting to discuss the application
  • The NDA includes the data from the study published in JAMA 2018 that demonstrated an 88% reduction in the risk of mortality in patients with Progeria treated with Zokinvy as monothx. After 2.2yrs follow up, Zokinvy reported lower mortality rate as compared with no treatment (3.7% vs 33.3%)
  • Zokinvy is an orally active inhibitor of farnesyltransferase, an enzyme involved in modification of proteins via prenylation and has received FDA & EMA’s ODD and FDA’s BTD & RPD designation

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