By Denny Jacob

 

Radius Health Inc. said Wednesday that the Menarini Group, with support from Radius, has submitted a new drug application to the U.S. Food and Drug Administration for elacestrant in patients with advanced or metastatic breast cancer.

Italian pharmaceutical company Menarini will take over activities and be responsible for registration and commercialization, based on the original agreement between the two sides, with the submission of the application, the companies said. Menarini plans to use Stemline Therapeutics, its U.S. subsidiary, to commercialize elacestrant if approved by the FDA, the companies said.

The two companies have requested priority review with the FDA as part of the submission. Radius, a biopharmaceutical company, and Menarini anticipate that the agency would conduct an eight-month review, incorporating a six-month priority designation review, if the priority review is granted, the companies said.

 

Write to Denny Jacob at denny.jacob@wsj.com

 

(END) Dow Jones Newswires

June 22, 2022 17:34 ET (21:34 GMT)

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