Amgen announced that data from several key Nplate (romiplostim) studies were presented at the 53rd Annual Meeting and Exposition of the American Society of Hematology (ASH). Final results from the international, Phase 3, open-label, single-arm ‘209 study evaluating the safety and efficacy of Nplate in adults with primary immune thrombocytopenia (ITP) demonstrated that Nplate induced a rapid platelet response in adult ITP patients with low platelet counts or bleeding symptoms and maintained a consistent safety profile.
In the study, incidence and type of adverse events (AEs) in patients treated with Nplate were consistent with those reported in previous studies. The most common side effects included headache, arthralgia and fatigue.
Approximately 90% of patients achieved each of the platelet response definitions, regardless of splenectomy status. Median time to response was one to two weeks. Over the course of the study, a doubling of the platelet count to greater than or equal to 50,000 platelets per microliter was achieved by 91% of patients who received Nplate. A platelet count increase of greater than or equal to 20,000 platelets per microliter from baseline was achieved by 93% of patients who received Nplate.
“We are very pleased to present the final results from the largest prospective study of Nplate in adult patients with primary ITP, which highlight Nplate’s ability to successfully treat these patients,” said Sean E. Harper, M.D., senior vice president of Global Development and chief medical officer at Amgen. “Additional data presented at the meeting in other disease states help further elucidate the safety and efficacy profile of Nplate. Collectively, these data help build upon our understanding of Nplate’s treatment potential for patients with thrombocytopenia.”
Date: December 13, 2011
Source: Amgen
