Promacta: Preliminary Phase III data

Preliminary data from the double-blind Phase III ENABLE 2 trial in 805 patients with HCV infection showed that Promacta plus standard of care (SOC; peginterferon alfa-2b and ribavirin) met the primary endpoint of a significantly greater proportion of patients achieving an SVR 24 weeks after the end of treatment vs. placebo plus SOC (19% vs. 13%, p=0.0202). Serious adverse events were reported in 20% of patients receiving Promacta vs. 15% for placebo, while thromboembolic events occurred in 4% and <1% of patients, respectively. The trial enrolled HCV patients with baseline platelets <75,000/u£ to receive open-label Promacta until platelets were >=100,000/u£. Patients achieving a platelet count of >=100,000/u£ were randomized to receive peginterferon alfa-2b and ribavirin in combination with Promacta or placebo. Data were presented at the American Association for the Study of Liver Diseases meeting in San Francisco last November. ...