Y-mAbs Therapeutics Inc. said the Committee for Orphan Medicinal Products of the European Medicines Agency has recommended the granting of orphan medicinal product designation in the E.U. for (177) Lu-omburtamab-DTPA for the treatment of medulloblastoma.
The biopharmaceutical company said the positive opinion has been sent to the European Commission, which is expected to grant the orphan drug designation within 30 days.
Y-mAbs said obtaining the designation for (177) Lu-omburtamab-DTPA is part of an overall plan to expand the company's European development programs and ultimately obtain orphan drug exclusivity to protect (177) Lu-omburtamab-DTPA for the treatment of medulloblastoma in the E.U.
Under the EMA, an orphan medicinal product designation gives companies access to protocol assistance and guidance on preparing a dossier that will meet European regulatory requirements and thereby maximize the chance of approval at the time of marketing authorization. Once approved, an orphan drug is also granted 10 years of market exclusivity during which directly competitive similar products cannot normally be placed on the market.
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