Amgen’s Osteoporosis Drug Wins European Nod, With a Heart Warning

Xconomy National — 

An osteoporosis drug developed by Amgen now has marketing approval in Europe, but it carries a warning that the medicine can raise the risk of cardiovascular problems.

Romosozumab (Evenity) treats postmenopausal woman who have osteoporosis, a disease that weakens bones, making them susceptible to fracture. The antibody drug, given as a monthly injection, was developed to block sclerostin, a protein involved in the signaling pathway that regulates bone growth. The drug is intended to provide a dual effect: It increases bone formation and reduces bone loss in patients who have the disease, which in turn reduces the risk of fracture.

The regulatory nod in Europe comes eight months after the FDA approved the medicine. That decision came two years later than Amgen (NASDAQ: AMGN) and partner UCB expected. In 2017, Amgen disclosed cardiovascular side effects in some patients treated with the drug in a Phase 3 study. The FDA later rejected the Amgen drug and asked for more data about its safety and efficacy.

The delay allowed a rival osteoporosis drug from Waltham, MA-based Radius Health (NASDAQ: RDUS) to beat Amgen to the market. That company’s daily injectable drug, abaloparatide (Tymlos), was approved in 2017. The Radius treatment provided an alternative to the Eli Lilly (NYSE: LLY) drug teriparatide (Forteo), which has been available to patients since 2002.

The FDA’s approval of romosozumab requires its label to carry a warning that the drug may increase the risk of heart attack, stroke, and cardiovascular death. It adds that physicians should assess whether the drug’s benefits outweigh those risks. The European Commission’s approval comes with a similar warning.

Romosozumab generated $104 million in global sales through the first nine months of this year, according to Amgen’s third-quarter financial report. In the same period, Radius reported that its osteoporosis drug generated $117.6 million in revenue, an 82 percent year-over-year increase.

Amgen and UCB anticipate the first launches of romosozumab in the European Economic Area in the first half of 2020.

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