Solvay Pharmaceuticals withdraws Synordia application

Solvay Pharmaceuticals has announced that its Fournier Laboratories Ireland subsidiary has withdrawn its application for marketing authorisation of Synordia in Europe.

The company has formally notified the European Medicines Agency of its decision to withdraw its application. Synordia is a proposed name for the combination of metformin and fenofibrate administered orally in a fixed dose.

The reason given for the withdrawal of the application first submitted in July 2006 is at the company could not respond to requests from the agency for additional information regarding the compound within the allotted timescale.

“Synordia is intended to be used as an adjunct to changes in diet and exercise to improve glycaemic control and dyslipidaemia in patients with type two diabetes,” the company reports.

It added that the intended recipients of Synordia are patients requiring both metformin and fenofibrate that have been stabilised on each compound.

Solvay Pharmaceuticals noted that the withdrawal of its application would not prejudice any future applications for the marketing authorisation of the compound that may be made in the future.

In July, the company reported that, if authorised, Synordia would be the first pharmaceutical available that combines an oral antidiabetic with a lipid lowering drug in a single pill.