The U.S. Food and Drug Administration (:FDA) recently granted priority review to Takeda Pharmaceutical Company Limited’s (TKPYY) Biologics License Application (:BLA) for vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (:UC). The company is looking to get vedolizumab approved for the treatment of adults with moderately to severely active Crohn’s disease (:CD) and UC. The BLA was filed in Jun 2013. While a response for the UC indication should be out in the first quarter of 2014, a response regarding the CD indication should be out in the second quarter of 2014.
Takeda’s regulatory filing on vedolizumab was based on positive results from the phase III GEMINI studies. GEMINI studies comprised a 4-study clinical program evaluating vedolizumab in 2,700 patients, who failed at least one conventional therapy, including glucocorticoids, immunomodulators and/or a tumor necrosis factor-alpha (TNF-α) antagonist.
Four distinct studies included an open-label long-term safety study in patients with either CD or UC (GEMINI LTS) and three placebo-controlled studies (GEMINI I, GEMINI II and GEMINI III). GEMINI I, an induction and maintenance study in patients with UC, showed that vedolizumab met the primary endpoints of improvement in clinical response at 6 weeks and clinical remission at 52 weeks.
GEMINI II, an induction and maintenance study in patients with CD, showed statistically significant improvement in the primary endpoint of clinical remission at 6 weeks and 52 weeks compared to placebo.
We note that Takeda is also seeking approval in Europe, where it submitted a Marketing Authorisation Application (MAA) in Mar 2013.
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