Janssen-Cilag receives CHMP recommendation for Zytiga
25 July 2011 00:00 in Pharmaceutical Company Product News
Janssen-Cilag has received a recommendation for European regulatory approval of its innovative new prostate cancer drug Zytiga (abiraterone acetate).
The European Medicines Agency's Committee for Medical Products for Human Use (CHMP) has granted a positive opinion endorsing the treatment for use among metastatic castration-resistant adult prostate cancer patients, in combination with prednisone or prednisolone.
An oral androgen biosynthesis inhibitor, the product has demonstrated its efficacy in a pivotal phase III clinical trial, showing its ability to improve overall survival rates among those whose conditions have progressed following chemotherapy.
The CHMP's positive opinion will now be referred to the European Commission, which will take a final decision in the third quarter of 2011.
Jane Griffiths, company group chairman for Janssen in Europe, the Middle East and Africa, said: "We will continue to work closely with the authorities to ensure abiraterone acetate becomes available as quickly as possible."
Last week, Janssen reported positive data from a phase III study of Edurant, its new treatment for adult HIV patients.
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