FDA Grants Approval of Koselugo to AstraZeneca Pharma

   By Stephen Nakrosis

The U.S. Food and Drug Administration on Friday approved Koselugo, or selumetinib, to treat certain pediatric patients with neurofibromatosis type 1.

The approval was given to AstraZeneca Pharmaceuticals LP.

The FDA said neurofibromatosis type 1 is a genetic disorder of the nervous system that can cause tumors to grow on nerves, adding it is a "debilitating, progressive and often disfiguring rare disease that typically begins early in life."

"Koselugo is approved specifically for patients who have symptomatic, inoperable plexiform neurofibromas, which are tumors involving the nerve sheaths (coating around nerve fibers) and can grow anywhere in the body," the FDA said.

The FDA's decision was based on a clinical trial conducted by the National Cancer Institute of pediatric patients who had NF1 and inoperable PN, it said.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

April 10, 2020 16:03 ET (20:03 GMT)

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