(AMGN - Free Report
) , along with its partner UCB S.A. (UCBJF - Free Report
) – a global biopharmaceutical company, announced that the FDA has accepted their Biologics License Application (BLA) for romosozumab for the treatment of osteoporosis in postmenopausal women. Romosozumab is being jointly developed by Amgen and UCB.
Romosozumab is an investigational bone-forming monoclonal agent designed to work by inhibiting and binding the activity of the protein sclerostin.
The BLA was submitted this July based on data from the pivotal phase III placebo-controlled fracture study in postmenopausal women with osteoporosis (FRAME).
Top-line results announced in February showed that the study had met the co-primary endpoints of reducing the incidence of new vertebral fracture through 12 and 24 months in postmenopausal women with osteoporosis. The study also met one of the secondary endpoints of reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women with osteoporosis through 12 months. However, it failed to meet another secondary endpoint of reducing the incidence of non-vertebral fractures through 12 and 24 months.
Data from the phase III FRAME study were published in the New England Journal of Medicine and were presented at a medical meeting in Atlanta this month.
The FDA has set a Prescription Drug User Fee Act (PDUFA) for romosozumab with a target action date of Jul 19, 2017.
Romosozumab is also being studied in a phase III fracture study in comparison to Merck & Co., Inc.’s (MRK - Free Report
) Fosamax (alendronate). Data from the study are expected in 2017.
Amgen has several interesting candidates in its pipeline, all of which represent significant commercial potential. The company focuses on therapeutic areas like inflammation and oncology, metabolism and bone, and cardiovascular and neuroscience. Through the rest of 2016, the company expects data from several pivotal programs. Important candidates in Amgen’s pipeline include Parsabiv (etelcalcetide; secondary hyperparathyroidism) and erenumab (AMG 334; episodic migraine).Zacks Rank & Key Picks
Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Anika Therapeutics Inc (ANIK - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can seethe complete list of today’s Zacks #1 Rank stocks here. The company’s earnings estimates for 2016 and 2017 were up a respective 12.6% and 14% over the last 60 days. It has recorded a positive earnings surprise in each of the last four quarters with an average beat of 42.19%. Anika’s shares have jumped 20.3% year to date.
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