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Merck receives diabetes drug labelling setback

Friday, April 7, 2017 8:25
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(Before It's News)

Merck & Co Inc (NYSE:MRK) suffered a rare setback as the US regulator rejected its application for a heart disease safety reference to be included with its diabetes best seller Januvia.

Merck wanted to highlight that a major trial involving the best seller drug indicated no heart problems for patients with type 2 diabetes.

This would have differentiated it from rivals known to have cardiovascular risks, such as Astrazeneca’s (LON:AZN) Onglyza.

Merck, though, received a Complete Response Letter from the US Food and Drug Administration on the use of Sitagliptin, the generic treatment for type 2 diabetes.

A complete response letter from the FDA means a drug will not be approved in its current form.

The pharma giant said it is reviewing the letter and will discuss its next steps with the FDA.

Shares eased  0.5% to US$62.95.

Story by ProactiveInvestors


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