The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has refused to recommend approval for Amgen and UCB’s Evenity (romosozumab) for the treatment of severe osteoporosis.
The agency said that as the benefits of Evenity did not outweigh its risks, it recommended refusal of the drug’s marketing authorisation.
The marketing authorisation application (MAA) of the drug was based on the findings of a large development programme, which included three phase 3 studies among others, which featured close to 12,000 patients.
Evenity was recently approved by the US Food and Drug Administration (FDA) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
CHMP said that its negative opinion was due to results suggesting that patients subjected to the drug had an increased risk of serious effects on the heart or circulatory system, including heart attacks or strokes.
Apart from that, CHMP said that when all the findings of the drug’s clinical development were looked at together, there were more deaths in patients aged more than 75 years who were subjected to the medicine.
The agency further said that as it was not clear why the drug seemed to increase the risk of heart and circulatory problems, and why there was no obvious group of patients in whom the risk of these was lower. As a result, the agency said that measures to lower the risk could not be readily put in place.
CHMP said that although Evenity was effective in lowering the risk of fracture in patients with severe osteoporosis, its benefit was not so convincing in those with less severe disease.
Amgen and UCB plan to seek a re-examination from the CHMP of their application for the drug.
Amgen research and development executive vice president David Reese said: “After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year, and these fractures can be life-changing.
“Yet these patients often remain undiagnosed and untreated and could benefit from a new treatment option with 12 monthly doses to reduce their risk of a fracture.
“We are disappointed by the Committee’s opinion and continue to believe that EVENITY has a positive benefit:risk profile.”