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Janssen Gets EU Approval for Prostate Cancer Drug Akeega

Janssen Gets EU Approval for Prostate Cancer Drug Akeega

Janssen Pharmaceuticals, a division of Johnson & Johnson, received European Commission marketing authorization for its prostate cancer drug Akeega (niraparib and abiraterone acetate), the first approval for the drug.

Akeega is given along with prednisone or prednisolone to treat adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

Prostate cancer is the most common cancer in men in Europe, and the sixth-highest cause of cancer-related death worldwide. The BRCA1/2 gene mutations, which are more likely to cause aggressive disease, poor outcomes, and a shorter survival time have been identified in approximately 10-15 percent of mCRPC patients, the company said.

In February, Janssen submitted a New Drug Application for Akeega with the FDA.

April 26, 2023

https://www.fdanews.com/

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