Today’s Daily Dose brings you news about FDA’s rejection of Amgen’s osteoporosis drug EVENITY; Trovagene’s stock offering and Emergent Bio’s acquisition of smallpox vaccine business from Sanofi.
The FDA has rejected Amgen Inc.’s (AMGN) investigational drug EVENITY, proposed for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
The U.S. regulatory agency has asked the Company to integrate the efficacy and safety data from an active comparator study of EVENITY in postmenopausal women with osteoporosis, dubbed ARCH, which was announced as recently as May of this year. It should be noted that the regulatory submission for EVENITY was made to the FDA last July based on data from a pivotal phase III study, dubbed FRAME.
In the new study, dubbed ARCH, treatment with EVENITY for 12 months followed by Merck & Co.’s (MRK) Fosamax significantly reduced the incidence of new vertebral, clinical and non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture, compared to Fosamax alone.
However, the rate of cardiovascular serious adverse events was higher in patients treated with EVENITY compared to Fosamax (2.5 percent EVENITY versus 1.9 percent Fosamax at 12 months) in the ARCH study, raising a concern. Amgen has itself said in May that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization, and that it does not expect approval of EVENITY in the U.S. to occur in 2017.
Besides the ARCH data, the FDA has also requested the Company to submit efficacy and safety data from a phase III trial evaluating EVENITY in men with osteoporosis, dubbed BRIDGE.
Amgen is collaborating with Belgium-based UCB SA for the development of EVENITY for the treatment of osteoporosis.
AMGN closed Friday’s trading at $177.13, up 1.19%.
Emergent BioSolutions Inc. (EBS) has agreed to acquire the ACAM2000 business of Sanofi (SNY) for $125 million in cash, diversifying its portfolio and…