1:10 PM
 | 
Apr 09, 2019
 |  BC Extra  |  Company News

FDA approves Evenity for osteoporosis

FDA approved Evenity romosozumab-aqqg from Amgen and UCB to treat osteoporosis in postmenopausal women at high risk of fracture. In January, an FDA advisory committee voted 18-1 in favor of the drug's approval (see "FDA Panel Backs Amgen's Evenity for Osteoporosis").

Evenity's label includes a black box warning describing risks of heart attack, stroke and cardiovascular death associated with its use, and says the drug should not be given to patients who have had a heart attack or stroke within the previous year.

The emergence of a previously unseen cardiovascular safety signal in a Phase III trial led FDA to issue a complete response letter in 2017 for Evenity's initial BLA submission. The partners' resubmission included data from two additional Phase III studies.

Amgen Inc. (NASDAQ:AMGN) said the approval requires a postmarketing assessment of Evenity's cardiovascular safety, including a five-year observational study.

Amgen spokesperson Trish Hawkins told BioCentury Evenity's price will be disclosed when the drug becomes available in about a week.

Japanese regulators approved Evenity in January for the same indication. The mAb against sclerostin is under EMA review.

Amgen was off $1.90 to $192.98 on Tuesday.

UCB S.A. (Euronext:UCB) lost €0.24 to €77.94. The approval came after European market hours.

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