Regulatory Affairs

FDA rejects Amgen’s BLA for osteoporosis treatment Evenity

PBR Staff Writer Published 18 July 2017

The US Food and Drug Administration (FDA) has rejected Amgen and UCB’s biologics license application (BLA) for Evenity (romosozumab) to treat postmenopausal women with osteoporosis

Evenity is an investigational bone-forming monoclonal antibody developed for the treatment of osteoporosis. The treatment is not yet approved by any regulatory authority.

The decision has been taken based on data from the pivotal phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis.

The agency has requested the efficacy and safety data from the Phase 3 active-comparator ARCH study to integrate with the application.

In addition, the resubmission will comprise of the efficacy and safety data from the BRIDGE study, which is a phase 3 trial assessing Evenity in men with osteoporosis.

Eventity has been assessed for its potential to reduce the risk of fractures in a global phase 3 program, which included two large fracture trials comparing Evenity to either placebo or active comparator in around 10,000 postmenopausal women with osteoporosis.

Fracture study in postmenopausal women with osteoporosis (FRAME) is a randomized, double-blind and placebo-controlled study, which assessed7,180 postmenopausal women with osteoporosis.

Active-conrolled fracture study in postmenopausal women with osteoporosis at high risk of fracture (ARCH) is a randomized, double-blind and alendronate-controlled study of Evenity in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.

The study assessed 12 months of Evenity treatment (210mg) followed by at least 12 months of alendronate treatment (70mg) compared with alendronate treatment alone to determine effectiveness in reducing the incidence of clinical fracture and new vertebral fracture.

As part of a collaboration and license agreement, Amgen and UCB have been working to research, develop and market antibody products targeting the protein sclerostin.

Amgen research and development executive vice president Sean Harper said: "During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, anticipated this request.”

Image: Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.