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Home Industry News Amgen applies for EU and US approval of Xgeva as multiple myeloma therapy

Amgen applies for EU and US approval of Xgeva as multiple myeloma therapy

7th April 2017

Amgen has applied for regulatory approvals in the US and Europe that will allow it to commercialise its drug Xgeva as a treatment for multiple myeloma.

A supplemental biologics licence application has been submitted to the US Food and Drug Administration, as well as an application for a variation to Xgeva's European Medicines Agency marketing authorisation, which seek to expand the currently approved indication for the prevention of skeletal-related events in solid tumours to include multiple myeloma.

Both applications are supported by new data from the pivotal phase III head-to-head '482 study, which represents the largest international multiple myeloma trial ever conducted. This data demonstrates Xgeva's non-inferiority to zoledronic acid in this indication.

Xgeva is a fully human monoclonal antibody that binds to and neutralises RANK ligand, a protein that plays a key role in the formation, function and survival of osteoclasts, which break down bone.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We look forward to collaborating with regulatory authorities to make Xgeva available to this patient population with an important unmet medical need."

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