FDA News

Amgen, UCB resubmit biologic license application for romosozumab

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Amgen and UCB have resubmitted a biologics license application to the FDA for romosozumab for the treatment of osteoporosis in postmenopausal women at high risk for fracture, according to a press release from both companies.

In July 2017, the FDA issued a complete response letter for the biologics license application for romosozumab (Evenity), asking Amgen to add safety and efficacy data from the ARCH and BRIDGE studies into the drug application. The original application, submitted to the FDA in September 2016, was based on efficacy and safety data from the phase 3 placebo-controlled Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) conducted in nearly 7,200 women. The investigational monoclonal antibody increases bone formation and reduces bone resorption simultaneously to increase bone mineral density and reduce the risk for fracture, according to the companies.

“A fracture due to osteoporosis can be a life-altering event, and Evenity has the potential to reduce fracture risk in patients at high risk due to a prior fracture,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “We look forward to continuing our work with the FDA to demonstrate the benefit0risk profile for Evenity. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.”

The biologics license application for Evenity includes results from two more recent pivotal phase 3 trials, including the ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture, and the BRIDGE study, including 245 men with osteoporosis. The FDA will evaluate the clinical risk-benefit profile of Evenity, including a cardiovascular safety signal seen in the ARCH study, for the potential to reduce the risk for fractures and increase BMD in postmenopausal women with osteoporosis.

The original FDA submission included data from a comprehensive phase 1 and phase 2 program and the phase 3 placebo-controlled FRAME study, including 7,180 postmenopausal women with osteoporosis.

“The burden of osteoporosis can have tremendous impact on a patient's life,” Pascale Richetta, MD, head of bone and executive vice president at UCB, said in a statement. “We are one step closer in our ability to bring this first-of-its-kind treatment to thousands of women affected by fragility fractures each year.”

As Endocrine Today previously reported, researchers found that postmenopausal women with osteoporosis randomly assigned romosozumab experienced a lower risk for new vertebral fractures vs. placebo at both 12 and 24 months, according to findings from the FRAME study published in The New England Journal of Medicine. Additionally, researchers found that patients assigned romosozumab also showed improvements in bone mass, with sustained benefits upon the transition to denosumab (Prolia, Amgen) after 12 months.

“Because of its dual effect to both stimulate bone formation and inhibit bone resorption, romosozumab improves bone density and bone strength quickly and markedly, resulting in rapid reductions in vertebral and clinical fracture occurrence across the skeleton,” Felicia Cosman, MD, medical director of the Clinical Research Center at Helen Hayes Hospital and professor of medicine at Columbia University College of Physician and Surgeons in New York, told Endocrine Today in a September 2016 interview.

The European Medicines Agency and the Pharmaceuticals and Medical Devices Agency in Japan are currently reviewing marketing applications for Evenity, and interactions with the agencies are ongoing, according to the companies. – by Regina Schaffer

Test.docx

Amgen and UCB have resubmitted a biologics license application to the FDA for romosozumab for the treatment of osteoporosis in postmenopausal women at high risk for fracture, according to a press release from both companies.

In July 2017, the FDA issued a complete response letter for the biologics license application for romosozumab (Evenity), asking Amgen to add safety and efficacy data from the ARCH and BRIDGE studies into the drug application. The original application, submitted to the FDA in September 2016, was based on efficacy and safety data from the phase 3 placebo-controlled Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) conducted in nearly 7,200 women. The investigational monoclonal antibody increases bone formation and reduces bone resorption simultaneously to increase bone mineral density and reduce the risk for fracture, according to the companies.

“A fracture due to osteoporosis can be a life-altering event, and Evenity has the potential to reduce fracture risk in patients at high risk due to a prior fracture,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “We look forward to continuing our work with the FDA to demonstrate the benefit0risk profile for Evenity. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.”

The biologics license application for Evenity includes results from two more recent pivotal phase 3 trials, including the ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture, and the BRIDGE study, including 245 men with osteoporosis. The FDA will evaluate the clinical risk-benefit profile of Evenity, including a cardiovascular safety signal seen in the ARCH study, for the potential to reduce the risk for fractures and increase BMD in postmenopausal women with osteoporosis.

The original FDA submission included data from a comprehensive phase 1 and phase 2 program and the phase 3 placebo-controlled FRAME study, including 7,180 postmenopausal women with osteoporosis.

“The burden of osteoporosis can have tremendous impact on a patient's life,” Pascale Richetta, MD, head of bone and executive vice president at UCB, said in a statement. “We are one step closer in our ability to bring this first-of-its-kind treatment to thousands of women affected by fragility fractures each year.”

As Endocrine Today previously reported, researchers found that postmenopausal women with osteoporosis randomly assigned romosozumab experienced a lower risk for new vertebral fractures vs. placebo at both 12 and 24 months, according to findings from the FRAME study published in The New England Journal of Medicine. Additionally, researchers found that patients assigned romosozumab also showed improvements in bone mass, with sustained benefits upon the transition to denosumab (Prolia, Amgen) after 12 months.

“Because of its dual effect to both stimulate bone formation and inhibit bone resorption, romosozumab improves bone density and bone strength quickly and markedly, resulting in rapid reductions in vertebral and clinical fracture occurrence across the skeleton,” Felicia Cosman, MD, medical director of the Clinical Research Center at Helen Hayes Hospital and professor of medicine at Columbia University College of Physician and Surgeons in New York, told Endocrine Today in a September 2016 interview.

The European Medicines Agency and the Pharmaceuticals and Medical Devices Agency in Japan are currently reviewing marketing applications for Evenity, and interactions with the agencies are ongoing, according to the companies. – by Regina Schaffer