Added indications recommended by EMA/CHMP

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), were several recommendations for additional indications for already approved medicines. These included:

German drug major Bayer (BAYN: DE) and partner Regeneron Pharmaceutical (Nasdaq: REGN) Eylea (aflibercept) Injection has been recommended for approval by CHMP for the treatment of visual impairment due to diabetic macular edema (DME). The decision of the European Commission is expected in the second half of 2014.Eylea is already marketed for other ophthalmic indications.

Also, Bayer’s oncology compound Stivarga (regorafenib) has been recommended for approval by the CHMP for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. The decision of the European Commission on the approval is expected in the third quarter of 2014. Stivarga is already approved in the European Union for the treatment of patients with metastatic colorectal cancer (mCRC).