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news.Sucampo Pharmaceuticals and Takeda Pharmaceutical Company and its wholly owned subsidiary, Takeda Pharmaceuticals North America, have announced that the FDA has approved Sucampo's supplemental new drug application for Amitiza 8mcg capsules twice daily to treat irritable bowel syndrome with constipation in women 18 years of age or older.
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As a result of this supplemental new drug application (sNDA) approval, Sucampo will receive a development milestone payment of $50 million from Takeda in accordance with the collaboration and license agreement between Sucampo and Takeda to jointly market Amitiza in the US and Canada.
The sNDA was based on a clinical study program that included two Phase III, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,154 adults, followed by one long-term, open-labeled extension trial involving 476 adults diagnosed with irritable bowel syndrome with constipation (IBS-C).
Art Rice, general manager, gastroenterology, of Takeda Pharmaceuticals North America, said: “We are prepared to rapidly roll out our extensive efforts together with Sucampo Pharmaceuticals to educate both physicians and adult women with IBS-C to help them understand the condition and how it may be treated with Amitiza.”