(CercleFinance.com) – Eli Lilly announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favorable opinion for Olumiant (baricitinib) as a treatment for severe alopecia (AA) in adults.
This decision is a first step towards European regulatory approval.
It is now up to the European Commission to take the final decision for a possible marketing on the old continent. The Commission’s decision is expected within one to two months.
Eli Lilly also recalls that Olumiant has had priority review status granted by the FDA since February 2022, still as a potential treatment for severe AA in adults. Regulatory decisions are also expected later this year in both the United States and Japan.
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