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EMA Adopts Negative Opinion For Zeftera

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on its Marketing Authorisation Application (MAA) for Janssen-Cilag International's (Janssen-Cilag ) antibiotic Zeftera, for the treatment of complicated skin and soft tissue infections.

Cilag International has given Basilea Pharmaceutica a notice of termination of the worldwide license, development and co-promotion agreement between the parties. The compound, including pending applications and in-market products, will be transitioned back to Basilea under the terms of the license agreement.

Zeftera (ceftobiprole medocaril for injection, henceforth known as ceftobiprole) is a cephalosporin antibiotic indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms in patients 18 years of age and older.

Janssen-Cilag International and Cilag GmbH International are Johnson & Johnson companies.