- Radius Health (NASDAQ:RDUS) announces that the Committee for Medicinal Products for Human Use's (CHMP) scientific group has issued a second Day-180 List of Outstanding Issues regarding its Marketing Authorization Application (MAA) seeking approval of Eladynos (abaloparatide-SC) for the treatment of postmenopausal women with osteoporosis at high risk of fracture. The group has requested additional analyses related to the safety and efficacy data. The company intends to promptly respond to the issues. CHMP should issue an opinion by the end of the year.
- If approved, it will be the first commercially available anabolic in Europe in 14 years. It was approved in the U.S. in April under the brand name TYMLOS.
- Previously: FDA OKs Radius Health's osteoporosis med TYMLOS; shares up 11% (April 28)