- GlaxoSmithKline (GSK) is seeking EMA approval for an expanded indication for Revolade (eltrombopag) to include severe aplastic anemia (SAA) in addition to its primary indication for thrombocytopenia.
- The FDA has already approved eltrombopag (marketed in the U.S. as Promacta) for the treatment of SAA.
- The EU generally issues final decisions within 60 days.
GSK is requesting a Revolade indication for treatment of patients who have had an insufficient response to immunosuppressive therapy. The FDA granted this same approval back in August.
Currently, Revolade is used to treat thrombocytopenia in patients with chronic immune thrombocytopenia purpura and patients with chronic hepatitis C so that they can initiate and maintain interferon-based therapy.
Considering that many hepatitis C patients who would have been treated with interferon-based therapy are now eligible for oral therapy, GSK's label expansion may help buffer the company against revenue losses from this target population.