Novartis Reports Positive Results for Revolade for Chronic/Persistent ITP

Rare Daily Staff

Novartis reported positive long-term results from a late stage study of Revolade, its approved therapy for adults with chronic/persistent immune thrombocytopenia, a rare and potentially serious blood disorder where the blood doesn’t clot as it should due to a low number of platelets.

The results of the study, published online in the journal Blood, found that a majority of patients maintained a substantial clinical response and many no longer needed to use other ITP medications simultatneously. The research evaluated patients for up to eight years of continuous treatment with a median exposure of 2.4 years.

The efficacy results of study demonstrated that median platelet counts were elevated within two weeks of Revolade treatment the benefits were maintained for more than four years. Post-baseline, overall bleeding rates declined and the majority of bleeding that occurred during the study were mild or insignificant. Some patients (39 percent) were capable of reducing or permanently stopping the use of one or more other ITP medications without the need for rescue therapy, many of which sustained reduction for at least 24 weeks.

Overall, the safety profile of Revolade was consistent with previous studies. The most common adverse events were headache (28 percent), nasopharyngitis (25 percent) and upper respiratory tract infection (23 percent). During treatment on the study, 6 percent of patients experienced thromboembolic events.

October 25, 2017