Basilea Pharmaceutica says that partner Johnson & Johnson has decided to discontinue sales of the superbug drug ceftobiprole in Canada.
J&J’s Janssen-Ortho unit will stop selling Zeftera (ceftobiprole) from April 16. The move comes after discussions with Health Canada in response to recent regulatory recommendations in the USA and European Union not to approve the drug for complicated skin and skin structure infections “due to concerns regarding the conduct of clinical trials”.
In February, the European Medicines Agency’s Committee For Medicinal Products for Human Use adopted a negative opinion on ceftobiprole, despite having originally backed the drug in November 2008. It has halted the authorisation process “pending completion and assessment of Good Clinical Practice inspections” and J&J has asked for a re-evaluation.
In December 2009, the US Food and Drug Administration said it could not approve the New Drug Application for Zeftera in its present form, saying Phase III results could not be relied upon because of concerns regarding the overall data integrity for both studies.
However, Zeftera was approved in Canada in June 2008 and Basilea notes that “there have been no safety observations that would be in conflict with the approved label”. The Swiss firm says that the decision to discontinue sales in the Canadian market does not preclude the submission of a new application for market authorisation in the future.
