The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use include good news for Novartis and Genzyme and setbacks for Gilead Sciences and Sanofi-Aventis.
First up, and the CHMP has issued a negative opinion on Cayston (aztreonam), Gilead’s treatment of chronic airway infections caused by Pseudomonas aeruginosa bacteria in adults with cystic fibrosis. The agency also recommended the refusal of Emerflu, Sanofi’s experimental pandemic flu vaccine.
However, the EMEA committee adopted a positive opinion on Novartis’ Glivec (imatinib) as a post-surgery treatment for patients at significant risk of relapse following removal of gastrointestinal stromal tumours. Also Genzyme’s Renvela (sevelamer carbonate) has been recommended for use in patients with chronic kidney disease.
A positive opinion was granted for Astellas’ Modigraf (tacrolimus) for the prophylaxis and treatment of transplant rejection in adult and paediatric kidney, liver or heart allograft recipients. Also receiving the CHMP’s backing is NeurogesX’ Qutenza (capsaicin) for the treatment of peripheral neuropathic pain in non-diabetic adults.
The committee also adopted a positive opinion for Krka’s Nimvastid, a generic version of Novartis’ Alzheimer’s and Parkinson’s disease drug Exelon (rivastigmine).
