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FDA Committee to Review Amgen's (AMGN) Osteoporosis Candidate

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Amgen Inc. (AMGN - Free Report) along with European partner UCB announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review its biologics license application (BLA) for Evenity (romosozumab) on Jan 16, 2019. Amgen is looking to get Evenity approved for the treatment of osteoporosis in postmenopausal women in the United States, who are at increased risk of fracture.

Evenity treats osteoporosis by increasing bone mineral density (BMD). Also, it reduces the risk of fracture.

The Evenity clinical program comprises three pivotal phase III studies, namely FRAME, ARCH and BRIDGE study. The FRAME study evaluated Evenity on postmenopausal women with osteoporosis. The ARCH study assessed the candidate on postmenopausal women suffering osteoporosis and who are at increased risk of fracture while the BRIDGE study evaluated Evenity on men with osteoporosis.

We remind investors that the first BLA seeking approval for Evenity regarding the same disease in the United States was issued a complete response letter (CRL) from the FDA in July 2017. The CRL was issued due to a cardiovascular side effect observed in the ARCH study. The BLA included data only from the FRAME program and the FDA then requested a resubmission of the application with additional data from the ARCH and the BRIDGE studies. This induced a delay in the drug’s approval.

However, in July 2018, Amgen along with UCB refiled the BLA for Evenity to the FDA.The second BLA now includes data from both ARCH and BRIDGE studies.

The marketing applications for Evenity are currently under review in Europe and Japan.

Shares of Amgen have rallied 19.8% so far this year versus the industry’s decline of 14.6%.

Apart from Evenity, Amgen has several interesting candidates with significant commercial potential in its pipeline, namely CNP520 (BACE inhibitor for Alzheimer's disease); tezepelumab (uncontrolled asthma) and omecamtiv mecarbil (chronic heart failure). All these candidates are in late-stage development and results from these pivotal programs are expected in the near term.

Zacks Rank & Stocks to Consider

Amgen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , Vanda Pharmaceuticals Inc. (VNDA - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alexion’s earnings estimates have been revised 5.3% upward for 2018 and 2.1% for 2019 over the past 60 days. The stock has gained 3% year to date.

Vanda Pharmaceuticals’ earnings estimates have been raised 112.5% for 2018 and 11.1% for 2019 over the past 60 days. The stock has soared 64.8% year to date.

Gilead Sciences’ earnings estimates have moved 5% north for 2018 and 4.8% for 2019 over the past 60 days. The stock has inched up 0.5% year to date.

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