Cinclus welcomes FDA announcement on single‑study requirement

“This announcement from the FDA is important for Cinclus Pharma and the development of linaprazan glurate,” CEO Christer Ahlberg says in a pressrelase.

Last week, FDA Commissioner Marty Makary and Vinay Prasad, the agency’s Chief Medical and Scientific Officer, stated in an article in the New England Journal of Medicine that they want to break with the principle from the 1960s that two independent pivotal studies should normally be required to demonstrate a drug candidate’s safety and efficacy, as previously reported by Life Science Sweden.