Merck & Co drops combo diabetes drug Janacti filing in Europe; presents data on discontinued vorapaxar study

15 November 2011

The European Medicines Agency says it has been formally notified by Merck Sharp & Dohme (Europe), a subsidiary of US drug giant Merck & Co (NYSE: MRK) of its decision to withdraw its application for a centralized marketing authorization for the medicine Janacti (sitagliptin and pioglitazone) and related trade names, 100/30mg and 100/45mg fixed-dose combination tablets intended to be used for the treatment of adult patients with type 2 diabetes mellitus.

The MA application for Janacti was initially submitted to the Agency on May 31, 2011. At the time of the withdrawal it was under evaluation by the Committee for Medicinal Products for Human Use.

In its official letter, the company stated that it is basing its decision to withdraw the application on a review of the regulatory and commercial prospects for the fixed-dose combination product. There are currently no ongoing clinical trials with Janacti. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.

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