Second Time's The Charm For Amgen As FDA OKs Bone-Building Osteoporosis Drug

Amgen, Inc. AMGN — which was in the news late last week over a legal battle with Novartis AG NVS over their migraine drug collaboration — now has a positive FDA decision to celebrate. 

Unique Drug Cleared

Amgen announced late Tuesday the FDA approved Evenity, chemically romosozumab-aqqg, for treating osteoporosis in postmenopausal women at high risk of breaking a bone.

Evenity is a monoclonal antibody that blocks the effects of the protein sclerostin and works by increasing new bone formation.

The large-cap biotech said it is the first and only bone-builder with a unique dual effect of increasing bone formation and to a lesser extent reducing bone loss, thereby rapidly reducing the risk of fracture.

One dose of Evenity consists of two injections, one immediately following the other, given once a month by a health care professional. A full course consists of 12 monthly doses.

Once Evenity therapy is completed, continued therapy with an anti-resorptive agent should be considered.

Chronic Widespread Disease

Osteoporosis is a chronic condition with no cure and affects millions of people worldwide, Amgen said, citing the World Health Organization. In the U.S. alone, about 10 million people suffer from the ailment.

"Each year, osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions," the company said. 

Annual costs from osteoporosis are expected to balloon to $25.3 billion by 2025.

Rebounding From The Initial Setback

Following the issue of a complete response letter in July 2017 on the pretext of adverse cardiovascular events, Amgen resubmitted the BLA for Evenity in July 2018.

The approval, however, comes with a rider: a post-marketing requirement from the FDA to assess the cardiovascular safety in postmenopausal osteoporosis women. This requires Amgen to carry out a five-year observational feasibility study, potentially followed by a comparative safety study or trial.

Amgen shares were trading up 0.35 percent to $193.66 at the time of publication Wednesday. 

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