EU adds new approval for Revolade in Thrombocytopenia

The European Commission has granted an additional indication for Revolade (eltrombopag), from Glaxo Smith Kline, as a treatment for Thrombocytopenia in adult patients with chronic Hepatitis C infection, where the degree of Thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon (IFN)-based therapy. Approval is is based on results from ENABLE-1 and -2, Phase III global, multicentre, two-part studies.

Results showed that eltrombopag enabled 95 percent of patients with chronic hepatitis C-associated thrombocytopenia to achieve platelet counts sufficient for initiation of pIFN-based therapy. Eltrombopag also enabled more patients to maintain pIFN-based therapy without dose reduction compared to placebo (45 percent vs 27 percent). Eltrombopag, indicated in adult patients as a once-daily oral therapy, was approved for chronic Hepatitis C-associated Thrombocytopenia by the EU on 19 September 2013.