Nothing like releasing bad news on a Friday evening. The drugmaker says the FDA "continues to review" the application for its Promacta treatment for chronic ITP beyond the September 19 action date. ITP, by the way, is an autoimmune disease that destroys blood platelets need for clotting and affects about 60,000 Americans. No specifics, however, were offered about the reason for the delay.
"Our discussions with the agency are progressing well and we look forward to this innovative new medicine becoming available for patients with ITP in the USA," Paul Huckle, Glaxo's senior vp for global regulatory affairs says in a statement.
Last May, an FDA advisory committee supported short-term use, defined as 6 weeks, which was the period studied, although some panel members raised concerns about long-term use. And FDA reviewers expressed about a failure to control bleeding any better than a placebo and Glaxo’s decision to seek approval for short-term use of a drug that may be used on a chronic basis (back story).