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Amgen Resubmits BLA to FDA for Osteoporosis Candidate Evenity

Zacks

Amgen Inc. AMGN and its partner UCB announced the re-submission of the biologics license application (“BLA”) to the FDA for Evenity (romosozumab). Amgen is looking to get Evenity approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture in the United States.

Evenity treats osteoporosis by increasing bone mineral density (“BMD”) and also reduces the risk of fracture.

Year to date, shares of Amgen have increased 11.6% as against the industry’s decline of 2.2%.


We remind investors that the first BLA seeking approval of Evenity for the same indication in the United States was issued a complete response letter (“CRL”) by the FDA in July last year. The CRL was issued due to a cardiovascular side effect observed in the ARCH study. The BLA included data only from FRAME study and the FDA then requested a resubmission of the application with additional data from the ARCH and the BRIDGE studies.

As required the second BLA now includes data from the ARCH and BRIDGE studies.

In the ARCH study, Evenity showed statistically significant superior fracture risk reduction in postmenopausal women compared to current standard of care for osteoporosis, Merck & Co., Inc.’s MRK Fosamax.

The FDA will review the potential of Evenity in increasing BMD as well as reducing risk of fracture and also cardiovascular safety signal from ARCH study.

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

Zacks Rank & Stocks to Consider

Amgen has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Eisai Co. ESALY and ChemoCentryx, Inc. CCXI, and H. Lundbeck A/S HLUYY. All of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Eisai’s earnings estimates have moved up from $1.77 to $1.94 for 2018 over the past 60 days and from $1.38 to $1.39 for 2019 over the past 30 days. The stock has rallied 68.1% so far this year.

ChemoCentryx’s loss per share estimates have narrowed from $1.02 to 82 cents for 2018 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 135.3%. The stock has rallied 128.8% so far this year.

H. Lundbeck’s earnings per share estimates have increased from $3.20 to $3.57 for 2018 and from $3.24 to $3.38 for 2019 in the past 60 days. The stock has rallied 38% so far this year.

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