The filing includes chemistry, manufacturing and controls (CMC) section of NDA for Gattex, which is indicated for the treatment of adults suffering from short bowel syndrome (SBS).
Previously, the company has released positive results from Steps Phase 3 trial evaluating the ability of Gattex to reduce PN and IV fluid requirements of adult subjects with SBS, demonstrated reductions in weekly PN and IV fluid volume and infusion days versus placebo.
NPS Pharma president and CEO Francois Nader said this rolling submission is an important milestone for NPS and brings them one step closer to commercializing Gattex.
"We believe Gattex represents an important treatment advance for patients with short bowel syndrome, and we look forward to submitting the remainder of our US marketing application later this year," Nader said.