The Committee for Medicinal Products for Human Use’s (CHMP) positive opinion is now referred for final action to the European Commission. Subject to approval by the European Commission, the positive CHMP opinion on Zevtera will apply in all 27 EU member states plus Iceland and Norway.
Ceftobiprole is marketed in Canada under the trade name Zeftera through co-promotion with Janssen-Ortho, a Johnson & Johnson company. Ceftobiprole is approved for the treatment of complicated skin and soft tissue infections including diabetic foot infections in Switzerland and currently under review for this indication by regulatory authorities in the US and other countries.
Anthony Man, CEO of Basilea Pharmaceutica, said: “This positive opinion represents a transforming landmark for Basilea and a major validation for Zevtera in the treatment of severe skin infections. Zevtera is now a step closer to being available for healthcare professionals and patients in Europe to fight against potentially deadly infections, including methicillin-resistant Staphylococcus aureus (MRSA) infections.”