Novo Nordisk has been boosted by the news that regulators in Europe have recommended approval of its investigational diabetes drug Victoza, three weeks after a US Food and Drug Administration panel expressed concerns about the drug.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on Victoza (liraglutide), the first once-daily human glucagon-like Peptide-1 (GLP-1) analogue for the treatment of type 2 diabetes. Specifically, the committee recommended the drug in combination with metformin and/or a sulphonylurea, or in combination with metformin and a thiazolidinedione, in patients who achieve insufficient glycaemic control with specified prior therapies.
Novo chief science officer, Mads Krogsgaard Thomsen, noted that “in clinical studies involving more than 6500 patients, Victoza has been shown to have a significant blood glucose lowering effect and lead to weight loss, while having a low risk of hypoglycaemia”. The company added that it expects to receive final marketing authorisation from the European Commission within two months and will then launch Victoza “in a number of European markets during this summer”.
Victoza is in the same class as Amylin/Eli Lilly’s blockbuster Byetta (exenatide) and Novo has presented data which shows that liraglutide provides statistically significantly better blood glucose control than exenatide. It also requires one injection per day, instead of two.
The response from European regulators is in marked contrast to the view put forward at the beginning of the month by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. It voted 8-5 that there is sufficient clinical data for liraglutide, to rule out “excess cardiovascular risk relative to competitors” but the panellists were split (6-6, with one abstention) as to whether data on thyroid tumours seen in studies on rodents permit approvability.
Other CHMP opinions
The CHMP also adopted a positive opinion on Nycomed’s Instanyl (fentanyl) as a nasal spray for the treatment of breakthrough pain in cancer patients who receive chronic opioid treatment for the management of their background pain. It also backed Chiesi’s caffeine-based Nymusa for the treatment of primary apnoea in premature newborns.
The committee also recommended expanded uses for two HIV drugs – Boehringer Ingelheim’s Aptivus (tipranavir) and Tibotec’s Prezista (darunavir), and Merck Sharp & Dohme’s diabetes treatments Janumet (sitagliptin/metformin) and Januvia (sitagliptin). However the CHMP adopted a negative opinion on extending the indication on Pfizer’s Lyrica (pregabalin) to cover fibromyalgia. The drug is currently authorised for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder in adults.
