May 22, 2017
By Alex Keown, BioSpace.com Breaking News Staff
THOUSAND OAKS, Calif. – Shares of Amgen are falling this morning after the company announced over the weekend it does not anticipate its experimental osteoporosis drug Evenity will be approved by the U.S. Food and Drug Administration this year.
On Sundaym Amgen released data showing that the Phase III Evenity (romosozumab) met primary and secondary endpoints in reducing the incidence of new vertebral, clinical and non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture. However, the data also showed the drug was causing cardiac issues with some of the patients. As a result of that new safety issue, Amgen said the FDA will want to assess the new safety concerns, which will cause the delay in what was expected to be a 2017 approval for the drug.
Shares of Amgen are down more than 2 percent as of 9:30 a.m., while shares of Belgium-based UCB, Amgen’s developmental partner, are down more than 16 percent in morning trading.
In the Phase III study, women received subcutaneous injection of EVENITY monthly for 12 months followed by oral alendronate weekly for at least 12 months. At 24 months, women in the Evenity treatment group experienced a statistically significant 50 percent reduction in the relative risk of a new vertebral fracture compared to those receiving alendronate alone, Amgen said. While the efficacy of the drug is positive, that safety risk is raising red flags neither company anticipated.
“The efficacy results from this study comparing Evenity to an active control are robust. At the same time, the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit: risk profile for Evenity,” Sean Harper, Amgen’s research and development head, said in a statement. “Together with UCB, we will engage with global regulators and medical experts in the field to conduct a thorough evaluation of these data.”
Evenity is an investigational bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin and has a dual effect on bone, increasing bone formation and decreasing bone resorption. In the Phase III study, dubbed Arch, the incidence of adjudicated cardiovascular serious events at 12 months was 2.5 percent for patients treated with Evenity compared to 1.9 percent for patients treated with alendronate.
Iris Loew-Friedrich, UCB’s chief medical officer, said the R&D team is working on “understanding the observed cardiovascular safety signal.” She added the companies will discuss results with global regulators and experts in the field as they attempt to move forward.
Amgen’s osteoporosis stumble was Radius Health ’s gain. Shares of Radius are up nearly 10 percent this morning. In April, the FDA approved its osteoporosis drug Tymlos. Phase III data that lead to approval of the drug showed that Tymlos reduces the risk of vertebral and non-vertebral fractures in postmenopausal women with osteoporosis.
Osteoporosis-related fragility fractures are common. In the United States, one in two women over the age of 50 will experience an osteoporotic fracture. Data shows that only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post fracture, Amgen said in a statement.
Last year, the company revealed positive results for Evenity in another Phase III study, dubbed Frame. In that study, the company said Evenity reduced vertebrae fracture rates by 73 percent compared to placebo after one year of taking the medication. Unlike the Arch study, Amgen said no imbalance in cardiovascular serious adverse events was seen in the 7,180-patient placebo-controlled Frame study.
