Merck Sharpe and Dohme receives CHMP backing for Remicade

Merck Sharpe and Dohme has been granted a recommendation for European approval of its drug Remicade for the treatment of severely active ulcerative colitis (UC).

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the use of Remicade among paediatric patients aged between six and 17 years old who are unable to benefit from other therapies.

This recommendation is based on positive safety and efficacy data from phase III studies and could help the drug to become the first biologic therapy approved in the EU for this specification.

Remicade is already available to adult UC patients and is also used in the treatment of inflammatory bowel disease and Crohn's disease.

Rupert Vessey, senior vice-president for Merck Research Laboratories, said: "The positive opinion adopted by the CHMP is encouraging news and a significant step towards making Remicade available to a younger patient population in Europe."

Last month, the company published new clinical trial data for the multiple myeloma drug Zolinza, showing its benefits when used in combination with bortezomib.