European CHMP Concludes Re-examination Of Ceftobiprole

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Dermatology;  Regulatory Affairs / Drug Approvals
Article Date: 27 Jun 2010 - 0:00 PDT

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Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that following a request for re-examination from the Applicant Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson company, the European Committee for Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI).

The CHMP has confirmed its previous negative opinion on the use of ceftobiprole for the treatment of cSSTI. The CHMP indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about the reliability of the results. The Committee therefore recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization.

In February 2010, the CHMP issued a negative opinion on ceftobiprole in cSSTI stating that inspections had shown that the phase III studies supporting the MAA had not been conducted in compliance with good clinical practice in some sites. Following the Applicant Janssen-Cilag's request for a re-examination of the negative opinion under standard procedures, the Agency has reassessed the MAA.

About ceftobiprole

Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic exhibiting activity against a wide spectrum of Gram-positive bacteria, including the 'superbug' methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumonia as well as many clinically important Gram-negative bacteria, including Pseudomonas.

Source:
Basilea Pharmaceutica Ltd.

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