EMA validates marketing authorization for pediatric alopecia areata treatment
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Key takeaways:
- Coacillium is the first and only drug candidate for children and adolescents that have both moderate and severe alopecia areata.
- The validation was based on positive results from the phase 2/3 RAAINBOW trial.
The European Medicines Agency has validated the marketing authorization application for coacillium for the treatment of moderate and severe alopecia areata in children and adolescents, Legacy Healthcare announced in a press release.
The application is now under the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) review.
Coacillium, an investigational botanical drug, is the first and only drug candidate for children and adolescents that have both moderate and severe forms of alopecia areata (AA).
“The validation ... is another important step towards our goal of bringing a potential treatment option to people with moderate and severe alopecia areata, starting with children and adolescents,” Saad Harti, CEO of Legacy Healthcare, said in the release.
The validation was based on data from the randomized, double-blind, placebo-controlled phase 2/3 RAAINBOW trial which evaluated coacillium 22.25% cutaneous solution in this patient population. Coacillium was “statistically significantly superior” vs. placebo in regard to relative change in Severity of Alopecia Tool score after 6 months of treatment, according to the release.
Additionally, the RAAINBOW trial findings showed that coacillium-treated patients with moderate AA experienced improvement, whereas placebo-treated patients experienced worsening severity.
No serious adverse events were reported; however, one adverse event of acute scalp and face eczema was determined to be caused by the treatment. Three other adverse events were considered “probably or possibly” related to treatment, according to the release.
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