It was all smiles at Swiss giant Novartis yesterday after Europe’s scientific advisory board gave the nod to Galvus (vildagliptin) for use in combination with metformin, thiazolidinediones or sulfonylureas – the broadest indication awarded to a DPP-4 inhibitor by the European authorities, it says - to combat type 2 diabetes in the estimated European patient population of 28 million.
The approval was based on data from more than 5,700 patients across 13 clinical studies, although the entire clinical experience with Galvus includes more than 21,000 patients of which around 10,000 received the new medicine, a so-called DPP-4 inhibitor that works by targeting the dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes.
Meanwhile the panel also gave its blessing to the approval of Novartis’ Aclasta (zoledronic acid 5 mg), a once-yearly treatment for postmenopausal osteoporosis, and its new transdermal Exelon (rivastigmine) patch for Alzheimer's disease - both of which have recently been cleared in the USA. So far this year Novartis has received a total of seven product approvals and four positive opinions from the US and European regulatory authorities. Final decisions on approvability are anticipated from the European Commission in three to four months.
Endorsement for Galvus safety
But is is Galvus that Novartis is particularly excited about. "Galvus is an important new treatment option for controlling type 2 diabetes because it provides beneficial blood sugar reductions without many of the side effects seen with other diabetes medications," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. And this is its biggest endorsement thus far: it is already available in Brazil and Mexico but stuttered in the USA when the country’s Food and Drug Administration delivered an ‘approvable’ letter for the drug requesting additional information back in February.
Novartis says it has now submitted a proposal to the FDA for additional studies in patients with renal impairment to confirm good tolerability in this patient group. And it stresses that the skin lesions seen in studies involving monkeys have not been seen either in healthy volunteers or in patients in the Galvus clinical trial programme who received the drug up to two years. Novartis suggested earlier this week that if its proposals are approved, then the study could be completed by the end of next year, putting it on track to re-file Galvus in mid-2009.