On January 16, 2019, by a vote of 18-1, the FDA’s bone, reproductive and urologic drugs advisory committee (BRUDAC) recommended that the FDA approve Amgen and UCB (Euronext Brussels)’s Evenity (romosozumab) osteoporosis treatment.
The lone dissent came from the committee’s patient representative.
It was the second review for the companies and came after the agency issued a Complete Response Letter in July 2017 for the Biologics License Application (BLA) for the Evenity injection. The agency’s response proposed a narrower indication of treatment for postmenopausal women with osteoporosis. The companies then resubmitted their application.
The committee voted in favor of that resubmission. Because there was a concern by committee members about the lack of data to analyze potential cardiovascular risk, the indication was further limited for the “treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as history in osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.”
A majority of the committee members recommended the companies conduct a post-approval study to obtain real-world data in a clinical setting. According to a report by RAPS, other committee members said it would be impossible to conduct such a post-approval study due to challenges with enrollment in clinical settings.
Evenity
According to the briefing materials supplied to committee members by Amgen, romosozumab is a “humanized monoclonal antibody (immunoglobulin G2) that inhibits sclerostin, thus having the dual protective action of promoting bone formation and decreasing bone resorption.”
The company said its BLA included data from approximately 14,000 subjects in 19 studies of the romosozumab clinical program.
The pivotal trial was a randomized, double-blind, placebo-controlled study in postmenopausal women with osteoporosis. Subjects were randomized to 12 months of romosozumab followed by 12 months of denosumab or to 12 months of placebo followed by 12 months of denosumab. “Romosozumab significantly reduced the risk of new vertebral fracture by 73% through month 12 and by 75% through month 24 (coprimary efficacy endpoints),” according to the company.
Click here for the 110-page Amgen committee materials.
Committee members are M.D.s with expertise in obstetrics, gynecology, epidemiology, urology, and geriatric medicine. Only one, Matthew Drake, M.D., Ph.D., from the Mayo Clinic reports expertise in bone disease.
David Reese, Amgen’s head of research and development, said, “women who are at high risk for fracture could benefit from an additional treatment option that has the potential to both build new bone and slow existing bone loss.”
