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news.Janssen-Cilag, part of the Johnson & Johnson family of companies, has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has decided to delay the European Commission decision process on Zevtera pending completion of a good clinical practice inspection.
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Zevtera (ceftobiprole medocaril) is in the final stage of approval for the treatment of complicated skin and soft tissue infections. This application for approval was based on the results of two, large, Phase III trials that demonstrated Zevtera was not inferior to comparator regimens as a treatment for complicated skin and soft tissue infections.
The regulatory review process is ongoing in the US and Australia, among other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections.
Ceftobiprole is licensed from and co-developed with Swiss based Basilea Pharmaceutica. Janssen-Cilag and Basilea Pharmaceutica will co-promote the drug in North America and key European markets subject to approval.