Amgen osteoporosis drug rejected
- Not a good start to the week for Amgen and UCB. Their codeveloped monoclonal antibody Evenity (romosozumab), which targets sclerostin, has received a complete response letter from the Food and Drug Administration. It was submitted for approval for use in postmenopausal women with osteoporosis.
- The FDA has asked for a resubmission, to include data from the comparator-controlled Phase 3 ARCH trial, which revealed a high rate of cardiovascular serious adverse events in the Evenity group compared with the Forteo (teriparatide) comparator group. The resubmission also must include data from the third pivotal study, BRIDGE, in men with osteoporosis.
- The original submission, made a year ago, was based on the placebo-controlled Phase 3 FRAME data, which showed no increase in cardiovascular severe adverse events.
After "dazzling" results in Phase 3, including superiority against Lilly's blockbuster Forteo (teriparatide), Amgen's Evenity (romosozumab) looked set to become a blockbuster itself. But bad news in May, when an unexpected cardiovascular signal cropped up, raised concerns about fast approval and launch. The cardiovascular issues came to light in a 12-month follow-up of patients in the ARCH study, where the incidence of CV serious adverse events was up to 2.5%, compared with 1.9% in the alendronate group.
This led to a not entirely unexpected turn down from the FDA and a request for more data. "During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, we had anticipated this request. We will use the additional time to better understand the benefit : risk profile of romosozumab," said Sean Harper, EVP of R&D at Amgen.
This decision from the FDA does open up the market for Radius Health's Tymlos (abaloparatide), which received approval from the FDA in April. Tymlos was the first bone-building drug to get a yes from the FDA for the treatment of postmenopausal women with osteoporosis in more than a decade. Its key competitors will be Eli Lilly's Forteo (teriparatide) and Amgen's Prolia (denosumab), both blockbusters. Forteo does face generic competition within the next year or two, which would be an economic challenge to Tymlos, and to Evenity, when it finally reaches the market.
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