Santen Pharmaceutical announced that the FDA has accepted for review the new drug application (NDA) for intravitreal sirolimus (440 µg), development code DE-109, for the treatment of noninfectious uveitis of the posterior segment. The FDA has set an action date of December 24, 2017 to complete its review of the intravitreal sirolimus NDA, per the Prescription Drug User Fee Act (PDUFA). Intravitreal sirolimus was granted orphan drug designation by the FDA and the European Commission (EC) in 2011.
Intravitreal sirolimus, an mTOR inhibitor, is an investigational first-in-class targeted, immunoregulator being developed by Santen for the treatment of patients with noninfectious uveitis of the posterior segment. Noninfectious uveitis of the posterior segment is a progressive and chronic inflammatory disease of the eye that can lead to vision impairment and blindness. The NDA for intravitreal sirolimus sirolimus is supported by data from the SAKURA Program, the largest phase 3 global clinical program to date evaluating patients with noninfectious uveitis of the posterior segment.
“The FDA acceptance of the NDA for intravitreal sirolimus is an important milestone, and brings us closer to potentially offering a locally-administered treatment option for patients with noninfectious uveitis of the posterior segment,” said Naveed Shams, MD, PhD, Chief Scientific Officer and Head of Global R&D at Santen, said in a company news release.