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Home Industry News Merck Sharp and Dohme reports positive clinical data for bezlotoxumab

Merck Sharp and Dohme reports positive clinical data for bezlotoxumab

21st September 2015

Merck Sharp and Dohme has announced new clinical data demonstrating the effectiveness of bezlotoxumab, its investigational antitoxin for prevention of C. difficile infection recurrence.

Data from two pivotal phase III clinical studies for bezlotoxumab showed the therapy met its primary efficacy endpoint by reducing rates of C. difficile recurrence for up to 12 weeks compared to placebo.

The treatment is designed for use in conjunction with standard-of-care antibiotics. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.

Based on these results, the company plans to submit new drug applications seeking regulatory approval of bezlotoxumab in the US, EU and Canada later this year.

Study lead investigator Dr Dale Gerding, professor of medicine at Loyola University Chicago Stritch School of Medicine, said: "Recurrence is a major challenge with C. difficile infection, and novel approaches are needed to help prevent the cycle of C. difficile recurrence."

This comes after the firm's skin cancer therapy Keytruda was provisionally recommended in draft guidance from the National Institute for Health and Care Excellence earlier this month.ADNFCR-8000103-ID-801800913-ADNFCR

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