The European Medicines Agency issued a negative opinion for Amgen Inc.’s Evenity, a drug to treat osteoporosis, according to a statement issued by the company on Friday.
The Thousand Oaks biotech company and UCB, a Brussels company, have been working together to develop the drug. Both companies intend to submit a written notice for the agency to re-examine Evenity for treatment in Europe.
“We are disappointed by the committee’s opinion and continue to believe that Evenity has a positive benefit-risk profile,” said Dr. David Reese, executive vice president of research and development at Amgen.
“Amgen and UCB remain committed to working with regulatory authorities around the world to bring Evenity to patients and physicians who need additional treatment options for osteoporosis.”
Although the opinion is a setback in the quest for the drug’s approval in Europe, Evenity was approved by the Food and Drug Administration in April and it has been approved in Japan, South Korea and Canada.
Shares of Amgen (AMGN) closed Friday up 26 cents, or a fraction of a percent, to $184.28 on the Nasdaq.