- 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.
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