Teva Pharmaceutical Industries Ltd (NYSE:TEVA) recently received positive feedback from a European Medicines Agency (EMA) committtee regarding its asthma drug candidate CINQAERO. The development brings Teva closer to commercialization of the treatment in the European Union. But that doesn’t take away all the uncertainties surrounding the anticipated launch of CINQAERO in the common market.
After EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval of Teva’s CINQAERO, the remaining major hurdle will be to get clearance from the European Commission. In the EU, it is the European Commission that has the authority to approve drugs for marketing in its member countries.
The remaining uncertainty for Teva Pharmaceutical with regards to obtaining final clearance to sell CINQAERO in Europe is that the European Commission is not legally bound to follow recommendations of its advisory panel. But Teva is hoping that it will do so regarding CINQAERO.
The European Commission is expected to issue its final decision regarding CINQAERO in the back half of 2016.
Positive study outcome
Teva’s CINQAERO is designed as an add-on treatment for adult patients suffering from severe asthma that has failed to respond positively to standard treatments. In clinical trials, CINQAERO (reslizumab), showed success in combating severe asthma. In particular, the drug candidate reduced asthma exacerbations and significantly improved lung function as well as life quality measures related to the disease.
According to Teva Pharmaceutical, approval of CINQAERO by the European Commission will open another much needed treatment option for patients in Europe afflicted by severe asthma.