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

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Eiger BioPharmaceutical