Daniel Daw | Sep 18, 2015

Merck issues pancreatitis advisory for users of diabetes drug

Merck unveiled an update to its portfolio of diabetes treatments on Thursday and provided information on a weekly treatment candidate for those with type 2 diabetes.

Januvia is the company's primary medication in this area of treatment, approved for use in the U.S. in 2006 and now prescribed in approximately 127 countries. It is considered an adjunct medicine that is meant to be combined with diet and exercise to stabilize glycemic levels in diabetes patients.

Merck said there have been post-marketing reports of pancreatitis in patients who have taken Januvia, which includes fatal, hemorrhagic and necrotizing forms. Merck advises patients and their physicians to be wary of signs and symptoms of pancreatitis while taking the medicine.

Merck also plans to submit a New Drug Application (NDA) for its weekly DPP-4 inhibitor, omarigliptin, to the Food and Drug Administration (FDA) by the end of 2015. This candidate has been endorsed by the Special Committee of the Japanese Pharmaceuticals and Medical Devices Agency. Merck expects the drug to be approved in Japan soon.

“At Merck, our priorities are driven by unmet medical need and our belief in Merck's ability to advance patient care, which is why diabetes remains a top priority,” Dr. Sam Engel, associate vice president of Merck clinical research, said. “Our teams are focused on bringing forward both scientific insights and new treatment options that can help patients and physicians better manage the challenges of diabetes. We have a strong portfolio of established medicines and continue to strengthen our role in the future of diabetes treatment through our own research and development, strategic collaborations and acquisitions.”

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+ Merck