FDA Issues CRL for Amgen’s and UCB’s Osteoporosis Drug

The US Food and Drug Administration (FDA) has issued a Complete Response Letter for the biologics license application (BLA) for Amgen and UCB’s Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis.

The original submission included data from Phase III placebo-controlled study of postmenopausal women with osteoporosis. With the availability of data from a Phase III active-comparator study, the agency has asked that the efficacy and safety data from the study be integrated into the application.

The resubmission will also include the efficacy and safety data from a Phase III trial evaluating Evenity in men with osteoporosis, which has also been requested. This request will be addressed in the form of a resubmission, which is an extension of the current review.

Evenity is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for treating osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables Evenity to increase bone formation and reduce bone resorption simultaneously, according to Amgen.

Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop, and market antibody products targeting the protein, sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for treating osteoporosis.

Source: Amgen


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