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 17:03 ET (21:03 GMT)

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