The latest set of opinions from the European Medicines Agency includes recommendations for Novartis’ meningitis B vaccine and two Sanofi drugs, one for diabetes and the other for colorectal cancer.
First up, the agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on Novartis’ Bexsero to immunise children from two months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B. In terms of meningitis, type B is the most common strain in Europe, and Novartis noted that Bexsero “is the result of more than 20 years of pioneering vaccine research”. Analysts believe the product is likely to be a blockbuster.
The CHMP also recommended approval for Sanofi’s Lyxumia (lixisenatide) for type 2 diabetes. The once-daily GLP-1 receptor agonist, licensed from Denmark’s Zealand Pharma, has “a pronounced post-prandial glucose lowering effect”, notes the French drugmaker, and is a “promising medicine that can be combined with other treatments, such as basal insulin”.
The EMA’s advisors have also backed Sanofi and Regeneron Pharmaceuticals’ Zaltrap (aflibercept) for infusion in combination with FOLFIRI chemotherapy for metastatic colorectal cancer (mCRC). The drug, which was given the green light by the US Food and Drug Administration in August, will likely get approval in Europe to treat patients who have disease that is resistant to or has progressed after an oxaliplatin-containing regimen.
Celgene loses Istodax appeal
However, the CHMP has confirmed its negative opinion for Celgene’s Istodax (romidepsin), intended for the treatment of peripheral T-cell lymphoma. In July, the company appealed the decision which was based on claims by the agency that the main study supporting the marketing application did not allow the committee to conclude on the clinical benefit of Istodax as it was not compared with any other treatment.
The CHMP had also noted that, due to an oversight, Celgene failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured. That problem has been sorted out but the committee still says it cannot conclude on the clinical benefit of the medicine in terms of overall or progression-free survival.
Other highlights of the CHMP meeting included positive recommendations on extending the label on Johnson & Johnson’s prostate cancer drug Zytiga (abiraterone) and its HIV treatment Intelence (etravirine), Novartis’ iron overload product Exjade (deferasirox) and Pfizer’s pneumococcal disease vaccine Prevenar 13.
