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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