Amgen Inc. and Belgium's UCB SA said a European Medicines Agency committee backed their osteoporosis drug Evenity for approval in the EU after a reexamination.
The EMA's Committee for Medicinal Products for Human Use, or CHMP, adopted a positive opinion for Evenity, or romosozumab, as a potential treatment for severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.
In June, the CHMP issued a negative opinion for the Amgen-UCB bone drug based on results of a development program which included a trio of phase 3 studies with nearly 12,000 patients.
Amsterdam-based EMA makes recommendations to the European Commission, which ultimately decides whether to approve or reject manufacturers' applications of drugs for marketing approval in the European Union.
The companies said a European Commission decision is expected later in 2019.
Evenity is approved in the U.S. and Canada for treating osteoporosis in postmenopausal women at high risk for fracture, and in Japan and South Korea for treating osteoporosis in women and men at high risk for fracture.
The medicine is also approved in Australia to treat osteoporosis in postmenopausal women at high risk for fracture as well as to increase bone mass in men with osteoporosis at high risk of fracture.
The U.S. Food and Drug Administration approval, however, required Evenity to carry a black-box warning — the regulatory agency's highest risk alert — after the drug showed heart safety risk in a late-stage trial.
Thousand Oaks, Calif.-based Amgen and UCB, in April, launched Evenity in the U.S. at a list price of $1,825 per dose, or $21,900 for a full 12-month course of treatment.