FDA issues complete response letter for Amgen, UCB's filing seeking clearance of Evenity for osteoporosis

Amgen and UCB announced that the FDA issued a complete response letter regarding a filing seeking approval of Evenity (romosozumab) for the treatment of postmenopausal women with osteoporosis. The companies noted that given the availability of data from the Phase III ARCH study, the agency asked that efficacy and safety data from the trial be included in the application.

In May, Amgen and UCB reported data from the ARCH study indicating that Evenity was associated with a higher rate of serious cardiovascular events versus Merck & Co.'s Fosamax (alendronate) in postmenopausal women with osteoporosis at high risk for fracture. Results from the trial revealed that "an imbalance in positively adjudicated cardiovascular serious adverse events was observed as a new safety signal," with rates of 2.5 percent for Evenity compared to 1.9 percent for Fosamax at 12 months. For further analysis, read ViewPoints: Out of the frying pan but into the fire for Amgen, UCB's Evenity.

At the time, Amgen noted that prior to its submission to the FDA, the company agreed with the agency that the ARCH data should be considered in the regulatory review, adding that as a result it "does not expect approval of Evenity in the US to occur in 2017." Amgen and UCB's filing to the FDA for Evenity was based on data from the Phase III FRAME study, which met all of its primary endpoints by reducing the incidence of new vertebral fractures through months 12 and 24 in postmenopausal women with osteoporosis.

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Amgen and UCB added Monday that the FDA also requested that the resubmission include efficacy and safety data from the Phase III BRIDGE study, which evaluated Evenity in men with osteoporosis. "During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorisation and, as a result, anticipated this request," remarked Sean Harper, executive vice president of R&D at Amgen.

Evenity is an experimental bone-forming monoclonal antibody that is designed to work by inhibiting the activity of sclerostin, which the companies suggest enables the drug "to rapidly increase bone formation and reduce bone resorption simultaneously."

For related analysis, see ViewPoints: Amgen, UCB keeping the faith in Evenity – albeit with lowered expectations.

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