Unanimous FDA advisory panel backing for NPS Pharma's Gattex

The US Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee yesterday voted unanimously to recommend approval of NPS Pharmaceuticals' (Nasdaq: NPSP) Gattex (teduglutide) for adults with short bowel syndrome (SBS).

Trading in NPS shares was suspended yesterday while the advisory panel deliberated on Gattex, but rose 19% to $10.86 last Friday after FDA staffers issued what were viewed as favorable briefing documents. The committee’s recommendation will be considered by the FDA in its review of the company’s New Drug Application for Gattex. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is December 30, NPS noted.

Last month, NPS’s partner, Japan’s largest drugmaker Takeda Pharmaceutical (TSE: 4502) received European Commission market authorization for the drug under the brand name Revestive (The Pharma Letter September 5). Gattex pricing has not been disclosed but drug's US peak sales potential is in the $350 million range, according to a recent The Street comment. Gattex has orphan drug designation in both the USA and European Union. An estimated 10,000 to 15,000 American adults have short bowel syndrome severe enough to require intravenous feeding.