Radius Health Inc. said it expects the European Medicines Agency to recommend against approving the company's osteoporosis treatment.
The Waltham, Mass.-based company was looking to market abaloparatide, approved as Tymlos in the U.S., to treat osteoporosis in postmenopausal women.
Osteoporosis is a condition characterized by fragile bones that raise the risk of fractures. The risk is especially higher in postmenopausal women.
At an oral explanation, the EMA's Committee for Medicinal Products for Human Use informed the company that it would not recommend the medicine for approval based on its benefit-to-risk profile.
Radius plans to appeal and immediately seek a re-examination of the committee's decision to reject its treatment.
The company's filing for the drug in the EU was backed by the same data that resulted in the treatment's approval in the U.S.
Radius Health President and CEO Jesper Høiland said that while the company was disappointed with the assessment, it would continue to work on the commercialization of the medicine in the U.S., the largest market in revenues for anabolics globally.