Y-mAbs’ 177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Receives Positive Opinion on Orphan Medicinal Product Designation by EMA
Obtaining OMPD for 177Lu-omburtamab-DTPA is part of an overall plan to expand the Company’s European development programs and ultimately obtain orphan drug exclusivity to protect 177Lu-omburtamab-DTPA for the treatment of medulloblastoma in the EU.
Under the EMA’s Regulation (EC) No. 141/2000 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.
The EMA grants orphan medicinal product designation based upon several criteria, including: the life threatening and debilitating nature of the condition; the medical plausibility of the proposed orphan indication; a prevalence in
Y-mAbs’ founder, Chairman and President,
Dr.
Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
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Source: Y-mAbs Therapeutics, Inc