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Safety Issues Force the FDA to Turn Down Amgen (AMGN), UCB SA's Osteoporosis Drug

7/17/2017 5:46:16 AM

Safety Issues Force the FDA to Turn Down Amgen, UCB's Osteoporosis Drug July 17, 2017
By Mark Terry, Breaking News Staff

Amgen (AMGN)’s setback is Radius Health (RDUS)’ advantage. The U.S. Food and Drug Administration (FDA) rejected Amgen’s and UCB’s Biologics License Application (BLA) for Evenity (romosozumab) for postmenopausal women with osteoporosis. Although this rejection won’t take Amgen out of the market, it does give Radius Health (RDUS) a solid lead.

The FDA issued a Complete Response Letter for Evenity, requesting that Amgen and UCB integrate efficacy and safety data from the ARCH and BRIDGE Phase III trials and resubmit.

“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,” said Sean Harper, Amgen’s executive vice president of Research and Development, in a statement. “We look forward to working through the review process with the agency. We remain committed to helping patients with osteoporosis and will use the additional time to better understand the benefit: risk profile of Evenity.”

Which begs the question, if they anticipated the request, why didn’t they include the data in the submission. As John Carroll, writing for Endpoints News, notes, the BRIDGE trial wrapped up more than a year ago. He asked the Amgen spokesperson why that data wasn’t given to the FDA and she indicated the company would “offer some added context” on July 25, at the company’s earnings review.

Evenity targets the sclerostin protein, and is given to the patient after prescribing Amgen’s Prolia (denosumab). Carroll writes, it “clearly vaulted the bar in Phase III for reducing vertebral fractures, with a hefty 75 percent 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, which recruited 7,180 postmenopausal women.”
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But Evenity failed to hit a key secondary endpoint, showing no significant improvement in the patient’s risks of non-vertebral fractures.

On April 28, Radius Health announced that the FDA had approved Tymlos (abalopratide) for postmenopausal women with osteoporosis at high risk for fracture. And, in trials, it cut the risk of vertebral and non-vertebral fractures.

Meanwhile, with Tymlos on the market, Radius Health announced today that Jesper Hoiland has been appointed president and chief executive officer. Kurt Graves, the company’s chairman, said in a statement, “We are pleased to welcome Jesper to Radius Health at this important time, and believe that he is uniquely qualified to lead Radius through the successful launch of Tymlos, and the advancement of our exciting clinical stage assets including elacestrant. Throughout his U.S. and Global leadership roles at Novo Nordisk (NVO), he demonstrated success in launching major brands, executing on business development and driving sustainable growth. His leadership and experience will be invaluable in guiding Radius through our next dynamic period of growth.”

Hoiland is replacing Bob Ward. Ward has been president and chief executive officer of Radius since December 2013.

Carroll writes, “While both Amgen and Radius have angled for an approval, 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.”

Forteo, marketed by Eli Lilly and Co. (LLY), will lose patent protection soon, and Lilly has pumped up the price to $3,100 a month, three times its price tag in 2010.

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