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 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.