The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
With fresh phase II ovarian cancer data in hand, Verastem Oncology Inc. plans to file an NDA by the end of the month for its avutometinib and defactinib combination treatment. The NDA will be for adults who have recurrent KRAS mutant recurrent low-grade serous ovarian cancer, a direction that may have caused the stock to wilt.
The U.S. FDA has approved the NDA for Sofdra (sofpironium) for treating excessive underarm sweating from Botanix Pharmaceuticals Ltd. The approval was based on two pivotal phase III studies and is approved for those ages 9 and older.
