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Phase 3 study of romosozumab / Courtesy of

Amgen Osteoporosis Drug Rejected by FDA

Walter Eisner • Fri, July 21st, 2017

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Amgen Inc.'s osteoporosis drug romosozumab (romo) has been rejected by the FDA.

On July 16, 2017, the company announced that its marketing application for the drug was rejected after missing a key secondary endpoint and running into recent safety issues. The FDA, according to the company, wants Amgen to include data from two late-stage studies—the ARCH study as well as a Phase III in men called the BRIDGE trial.

John Carroll, editor-in-chief of Endpoints News, asked the company why the data hadn't already been supplied to the FDA. The study was completed more than a year ago. The company told Carroll, “Based on original discussions with FDA, the FRAME study was sufficient for initial BLA (Biologics License Application) submission. The pivotal 7,180-patient FRAME trial was the first to evaluate vertebral fracture risk reduction as early as one year as a primary endpoint.”

“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, anticipated this request. We look forward to working through the review process with the Agency,” said Sean Harper, executive vice president of R&D at Amgen.

Carroll wrote that the drug "clearly vaulted the bar in Phase III for reducing vertebral fractures, with a hefty 75% risk reduction compared to a placebo plus denosumab. Investigators also were able to show a better safety profile in its presentation at the annual confab of the American Society for Bone Mineral Research. And there was an increase in bone mineral density among the drug arm in the study."

However, he added that the drug also missed a key secondary endpoint in the pivotal program. "The drug did not significantly improve patients’ risk of non-vertebral fractures."

In May, the company issued a note spelling out a disturbing cardio risk imbalance between romo and Fosamax; 2.5% for romo and 1.9% for Fosamax. The company, according to Carroll had expected an approval this summer, but regulators "made it clear they wanted to evaluate the full set of data in sizing up an approval."

While Amgen and its competitors have angled for an approval, Carroll said commercial success is a completely different issue. "As The New York Times reported recently, patients are generally started on bisphosphonates like Fosamax, which are old and cheap. But they’re also limited, unable to build bone the way Forteo and the two new drugs are designed to do."

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