RTTNews | Jun 25, 2021 07:57AM EDT

07:56 Friday, June 25, 2021 (RTTNews.com) - BioMarin Pharmaceutical Inc. (BMRN) said that the Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending marketing authorization for vosoritide, a once daily injection analog of C-type Natriuretic Peptide or CNP to treat achondroplasia in children from the age of 2 until growth plates are closed, which occurs after puberty when children reach final adult height. Achondroplasia is the most common form of disproportionate short stature in humans. A final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission in third-quarter 2021. Vosoritide is potentially the first medicine to be approved to treat children with achondroplasia in Europe and would be marketed under the brand name VOXZOGO (vosoritide).

In addition, the French National Agency for Medicines and Health Products Safety granted temporary authorization for Use to allow access and reimbursement of vosoritide to begin immediately.

The U.S. New Drug Application for vosoritide is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of November 20, 2021.

Read the original article on RTTNews ( https://www.rttnews.com/3205064/biomarin-gets-positive-chmp-opinion-for-vosoritide-to-treat-achondroplasia.aspx)

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