Ontozry Wins English Funding For Drug-Resistant Epilepsy
Heath technology assessment body NICE estimates that around 17,000 patients would be eligible for treatment with Arvelle’s drug.
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Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.
Around 13,000 people are now expected to be eligible for treatment with the long-acting, injectable Vocabria/Rekambys combination therapy in England.
Sanofi argues that the European Medicines Agency applies a narrow interpretation of its new active substance principles which is not appropriate for biological therapies, and that the regulator fails to consider the challenges of conducting clinical research in rare diseases.