The European Medicines Agency has refused marketing authorizations for an herbal medicine intended to treat alopecia areata and a hybrid drug for neuroblastoma in children.
The applicant, Legacy Healthcare S.A.S., presented results of a study in 107 children aged 2-17 with moderate to severe alopecia areata affecting between 25% and 95% of the scalp. They were treated with twice-daily sprays of Cinainu or a placebo for 24 weeks, looking for improvements in the SALT score, a standard rating score for alopecia. However, study results"did not show that the medicine was effective in treating moderate to severe alopecia areata," the CHMP said.
Therefore, the committee’s opinion was that the benefits of Cinainu did not outweigh its risks and it recommended refusing marketing authorization. The company may ask for a re-examination within 15 days of receiving the opinion on November 14.The CHMP also recommended refusal of Orphelia Pharma's application for marketing authorization for Kizfizo , which had been intended for the treatment of high-risk neuroblastoma in children older than 1 year, as combination therapy with either.
Neuroendocrine Tumour NET Nets Neuroendocrine Tumor (NET) Neuroendocrine Tumors (Nets) Neuroendocrine Tumour (NET) Neuroendocrine Tumours (Nets) Drug/Treatment Safety Drug Safety Treatment Safety Drug Development Drug Discovery Drug Pipeline Drug Development Pipeline Drug Legislation Drug Registries Drug Registry Drug Regulation Neuroblastoma Children Child
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