FDA rejects expanded use of Amarin's Vascepa
This article was originally published in Scrip
Shares of Amarin tumbled about 10% on 28 April after the company disclosed the FDA declined to expand the use of Vascepa (icosapent ethyl) in the US as an adjunct to diet to reduce triglyceride (TG) levels in adults on statin therapy with mixed dyslipidemia and TG levels from 200mg/dL to 499mg/dL – the so-called ANCHOR indication.
You may also be interested in...
The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.
Moderna raised $500m to fund its growing pipeline, choosing once again to stay private rather than pursue an IPO. Also, AvroBio closed a $60m Series B round to advance its gene therapies for lysosomal storage disorders, Seattle Genetics led recent public company financings, and Vical is restructuring.
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.