GlaxoSmithKline Gets FDA Nod for Promacta/Revolade
GlaxoSmithKline has notched another regulatory victory. The company announced Monday that that Food and Drug Administration has granted breakthrough therapy status for its Promacta/Revolade, a drug intended to treat cellular deficiencies in sufferers of severe aplastic anemia.
The affliction is an uncommon disorder in which the body's bone marrow does not manufacture a sufficient amount of new blood cells.
Breakthrough therapy is a relatively new designation from the FDA. In the regulator's words it "is intended to expedite the development and review of drugs for serious or life-threatening conditions."
Ligand Pharmaceuticals will also benefit from the FDA's ruling. It is partnering with GlaxoSmithKline and holds Promacta in its portfolio. In a press release, Ligand CEO John Higgins said the treatment "continues to be the basis of ground breaking and promising science in important areas with significant unmet medical needs."
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