Belgium-based Solvay Pharmaceuticals has suspended regulatory activities in the USA for its irritable bowel syndrome drug Calmactin (cilansetron).
The firm said it compared the Food and Drug Administration’s clinical requirements for approval against the estimated market potential for the product, and reached the conclusion that its efforts should focus on the development of other candidates in the pipeline.
On the other side of the Atlantic, however, discussions with the Medicines and Healthcare products Regulatory Agency regarding the agent’s approval in Europe, where the UK is acting as a member reference state, are ongoing, with a decision expected next year.
On a more positive note, Solvay says it has now obtained marketing authorization for its Parkinson’s disease drug Duodopa (levodopa/carbidopa) in 28 European countries, after recently gaining access to a further 13 European countries via the Mutual Recognition Procedure.
The firm notes that the procedure was particularly fast in this case as both the European Agency for the Evaluation of Medicinal Products and the European Committee have supported the regulatory authorities in the various countries in view of Duodopa’s orphan drug status. And in the USA, ongoing consultations with the FDA should see the start of clinical work next year to support a New Drug Application submission in 2007, the group noted.
