FDA Mycapssa Snub Whacks Chiasma; New Study Needed
This article was originally published in Scrip
The FDA tried to warn Chiasma Inc. in 2014 its single-arm, open-label Phase III trial may not be enough to pass muster for the agency to approve the company's new drug application (NDA) for its investigational acromegaly drug Mycapssa (octreotide) and pointed out having a controlled trial would be a better option.
You may also be interested in...
Chiasma has bounced back from a 2016 CRL for Mycapssa with a new SPA-agreed Phase III trial meeting all its primary and secondary endpoints. The product is positioned to be the first oral treatment for acromegaly.
With a near-term launch of Mycapssa unlikely, Chiasma cuts its commercial staff while it evaluates how to respond to an April complete response letter.
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.