Benzinga | Jun 25, 2021 01:30PM EDT

EMA's Advisory Committee Backs Approval Of BioMarin's Dwarfism Candidate

* European Medical Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of BioMarin Pharmaceutical Inc (NASDAQ:BMRN) vosoritide for achondroplasia in children aged two years and above until growth plates are closed, which occurs after puberty.

* Achondroplasia is the most common form of disproportionate short stature in humans.

* A final approval decision is expected from the European Commission in Q3 2021.

* If approved, vosoritide will be potentially the first approved medicine to treat children with achondroplasia in Europe and be marketed under the brand name Voxzogo.

* The opinion is based on the totality of data from the vosoritide program, which showed that growth rates had been sustained.

* No acceleration of bone age was observed, suggesting that vosoritide is not reducing the total duration of the growth period.

* Price Action: BMRN shares are up 0.99% at $84.61 during the market session on the last check Friday.