“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA
The US Food and Drug Administration has granted “Breakthrough Therapy” designation for UK pharma giant GlaxoSmithKline’s (LSE: GSK) Promacta/Revolade (eltrombopag) for the treatment of cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy (IST).
Eltrombopag is not approved or licensed anywhere in the world for use in this treatment setting, although it has been cleared for marketing in other indications, such as idiopathic thrombocytopenic purpura, since 2008. Breakthrough Therapy Designation is the newest of the FDA’s programs aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.
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