Merck, AstraZeneca Get EMA Orphan Designation for Selumetinib
August 03 2018 - 9:41AM
Dow Jones News
By Colin Kellaher
Merck & Co. (MRK) and AstraZeneca PLC (AZN.LN, AZN) on
Friday said the European Medicines Agency granted orphan
designation to selumetinib for neurofibromatosis type 1, or NF1, an
incurable genetic condition that affects one in 3,000 newborns
worldwide.
The pharmaceutical companies said they are studying the
potential benefit of selumetinib in pediatric patients with
inoperable NF1-related plexiform neurofibromas, which are benign
tumors on nerve sheaths that develop in 20% to 50% of patients. As
the tumors increase in number and size, they can cause
moderate-to-severe morbidities such as pain, motor dysfunction and
disfigurement, the companies said.
The EMA grants orphan status to medicines designed to treat,
prevent or diagnose seriously debilitating or life- threatening
diseases found in no more than five people in 10,000 in the
European Union. The U.S. Food and Drug Administration granted
orphan-drug status to selumetinib in February.
AstraZeneca licensed selumetinib from Array BioPharma Inc.
(ARRY) in 2003 and signed a co-development and co-commercialization
agreement for the drug with Merck in 2017.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 03, 2018 10:26 ET (14:26 GMT)
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