GlaxoSmithKline Gets FDA Approval for Blood-Disorder Drug Nucala
September 25 2020 - 05:18PM
Dow Jones News
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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