LONDON (Alliance News) - GlaxoSmithKline PLC said Monday that it had received Breakthrough Therapy designation for its bone marrow disorder treatment Promacta/Revolade from the US Food and Drug Administration.
The treatment is designed for patients with severe aplastic anemia, a rare disorder in which bone marrow fails to make enough new blood cells, and who have had insufficient responses to immunosuppressive therapy.
Breakthrough Therapy designation is used to speed up the development and review of drugs that treat serious or life-threatening medical conditions. The designation was based on results from the Phase II National Institute Health study of the treatment.
There are no approved therapies available for the treatment of patients with the disorder that are unresponsive to initial immunosuppressive therapy.
Immunosuppressive therapy is the deliberate reduction of the activation of efficiency of the immune system, often used to prevent the body rejecting an organ transplant or the treatment of auto-immune diseases.
Shares in Glaxo were trading up 1.2% at 1,582.59 pence Monday morning.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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