Y-mAbs Therapeutics Gets OMPD in E.U. for Medulloblastoma Treatment
June 25 2021 - 09:37AM
Dow Jones News
By Chris Wack
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.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
June 25, 2021 09:27 ET (13:27 GMT)
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