European CHMP adopts negative opinion on ceftobiprole

23-Feb-2010 - Switzerland

Basilea Pharmaceutica Ltd. announced that the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI). The sponsor Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson company, has been notified that the CHMP adopted a negative opinion on the MAA for ceftobiprole for the treatment of cSSTI.

The MAA for ceftobiprole for the treatment of cSSTI was filed by Janssen-Cilag in June 2007. After a positive opinion from the CHMP in November 2008, the European Medicines Agency took the unusual step of halting the European Commission authorization process on ceftobiprole pending completion and assessment of Good Clinical Practice (GCP) inspections.

The CHMP now stated that inspections showed that the phase III studies supporting the MAA had not been conducted in compliance with GCP in some sites. The CHMP indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about how reliable the results were. The Committee therefore recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization.

Janssen-Cilag aims to discuss with the CHMP as soon as possible the best path forward for ceftobiprole in Europe.

Basilea is committed to take those steps necessary to allow ceftobiprole to be more widely available to patients in need of new treatment options to fight potentially deadly resistant bacterial infections. The company is reviewing all strategic options to protect the interests of the company and its shareholders.

https://www.bionity.com/en/news/113777/european-chmp-adopts-negative-opinion-on-ceftobiprole.html