Shire resubmits lifitegrast NDA

Shire plc (LSE:SHP; NASDAQ:SHPG) resubmitted an NDA to FDA for lifitegrast ( SHP606) to treat signs and symptoms of dry eye. The company had received a complete response letter from FDA in October requesting an additional clinical study and product quality information.

The week after it received the complete response letter, Shire said lifitegrast met the primary endpoint in the Phase III OPUS-3 trial to treat dry eye. Shire said Monday that the resubmitted NDA includes data from three Phase III trials including OPUS-3, along with the product quality information requested by FDA (see BioCentury Extra, Oct. 27, 2015). ...