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GlaxoSmithKline Gets FDA Nod for Promacta/Revolade

By Eric Volkman – Feb 3, 2014 at 4:35PM

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GlaxoSmithKline's treatment receives breakthrough therapy designation from the regulator.

GlaxoSmithKline (GSK 0.91%) 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 (LGND 3.81%) 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." 

Eric Volkman has no position in any stocks mentioned. Nor does The Motley Fool. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Stocks Mentioned

GSK plc Stock Quote
GSK plc
GSK
$35.35 (0.91%) $0.32
Ligand Pharmaceuticals Stock Quote
Ligand Pharmaceuticals
LGND
$72.66 (3.81%) $2.67

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