FDA reviewing Santen's uveitis candidate

Santen Pharmaceutical Co. Ltd. (Tokyo:4536) said FDA accepted for review its NDA for intravitreal sirolimus (DE-109) to treat non-infectious uveitis of the posterior segment. The PDUFA date is Dec. 24.

The formulation of rapamycin, an inhibitor of mammalian target of rapamycin (mTOR; FRAP; RAFT1), has Orphan Drug designation in the U.S. and Europe...