DJ GlaxoSmithKline Gets FDA Approval for Blood-Disorder Drug Nucala
By Kimberly Chin
GlaxoSmithKline PLC has received the U.S. Food and Drug Administration's approval for the drug Nucala, which treats adult and pediatric patients with hypereosinophilic syndrome, a type of blood disorder.
Nucala will become the first and only targeted biologic treatment to win approval for patients with eosinophil-driven disease in the U.S., the company said. Eosinophils are a type of white blood cell.
The FDA's approval follows a review of data from the company's Phase 3 study, GlaxoSmithKline said. The results showed 50% fewer patients experienced worsening symptoms or required an escalation in treatment compared with the use of a placebo, the company said.
The results were recently published in the Journal of Allergy and Clinical Immunology.
Nucala is currently used as treatment for several other eosinophil-driven diseases.
Write to Kimberly Chin at kimberly.chin@wsj.com
(END) Dow Jones Newswires
September 25, 2020 16:48 ET (20:48 GMT)
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