Novartis has secured two recommendations for approval from advisors to the European Medicines Agency – the cancer drug Tasigna and a diabetes combination containing Galvus.
Starting with Tasigna (nilotinib), the EMEA’s Committee for Medicinal Products for Human Use has recommended the drug for the treatment of chronic myeloid leukaemia in patients who are unable to take the Swiss firm’s current blockbuster Gleevec/Glivec (imatinib). The recommendation is based on a 320-patient Phase II study which showed how Tasigna reduced or eliminated cells carrying the abnormal Philadelphia chromosome, recognised as the key driver of the overproduction of cancer-causing white blood cells in patients with CML, in nearly half of patients (49%) with the chronic phase of the disease.
David Epstein, head of oncology at Novartis, said that Tasigna represents “a tremendous advance for the small number of patients who develop resistance or intolerance to Glivec". The drug has been approved in Switzerland and although the Food and Drug Administration extended its review period by three months in July, a regulatory decision in the USA is still expected by year-end.
Meantime, the CHMP has given a positive opinion on a new oral tablet combining Galvus (vildagliptin) and metformin as a new treatment for patients with type 2 diabetes. The treatment, which is called Eucreas, will be the first single-tablet combination of a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin to get the go-ahead in Europe. Galvus on its own only received a recommendation from the CHMP in July.
Emanuele Bosi, director of the diabetes and endocrinology unit at San Raffaele University Hospital in Milan, said that Eucreas demonstrates additional significant blood sugar reductions and is well tolerated. Also the combination “does not cause weight gain and has a low incidence of hypoglycaemia, the two most common side effects of current treatments for patients with type 2 diabetes”.
All good news for Galvus and its combinations in Europe, but on the other side of the Atlantic, regulators are less enthusiastic. The company only received an approvable letter for Galvus from the FDA in February and was asked to provide further clinical trial data in patients with moderate to severe renal impairment and that data are unlikely to be available before 2009.
The CHMP also recommended approval of Takeda Pharmaceutical Co's combination of Actos (pioglitazone) and metformin.