FDA accepts NDA for Lutathera
Advanced Accelerator Applications S.A. (NASDAQ:AAAP) said FDA accepted for review a resubmitted NDA for Lutathera (177-Lu-Dotatate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The PDUFA date is Jan 26, 2018.
FDA issued a complete response letter for the candidate last December. Advanced Accelerator had said the letter did not ask for additional trials, but requested subgroup and safety analyses, and asked the company to resolve manufacturing concerns (see BioCentury Extra, Dec. 21, 2016).
Lutathera is a radiolabeled somatostatin analog that targets somatostatin receptors. This month, the U.K.’s NICE issued draft guidance recommending against the use of the product, which EMA’s CHMP has recommended for approval (see BioCentury Extra, Aug. 3).
The company has rights to Lutathera from Covidien plc, which Medtronic plc (NYSE:MDT) acquired.
投資の参考になりましたか？
