Novo Nordisk has been granted a first approval for its ultra long-acting insulin degludec, in Japan, and has discontinued development of a Phase III haemophilia drug.
The Japanese Ministry of Health, Labour and Welfare has approved Tresiba(insulin degludec) for the treatment of diabetes, some nine months after the once-daily treatment was filed in the country. The green light is based in part on Japanese studies which revealed that the duration of action for Tresiba has been tested up to 26 hours, compared with over 42 hours for the global programme.
The latter has involved close to 10,000 people with type 1 or type 2 diabetes and Novo notes that in the "treat-to-target" studies, when compared to Sanofi's blockbuster Lantus (insulin glargine), Tresiba achieved equivalent reductions in HbA1c and was associated with significantly lower risk of nocturnal hypoglycaemia. The company expects to launch the in Japan as soon as price negotiations have been completed.
The road to approval for Tresiba has been trickier in the USA. In July, the Food and Drug Administration said that Tresiba and the insulin combination analogue Ryzodeq (degludec/aspart) will face an advisory committee on November 8; a month earlier, the agency had extended the regulatory review period for the two therapies by three months and asked for further data clarification.
Meantime, Novo has also revealed that it will discontinue development of its haemophilia treatment vatreptacog alfa.
The decision follows analysis of Phase III data covering 72 patients with inhibitors were treated on demand with either vatreptacog alfa or Novo's older haemophilia drug NovoSeven (recombinant Factor VIIa) in random sequence as bleedings occurred. In total, 567 bleeding episodes were treated.
The trial demonstrated that both vatreptacog alfa and NovoSeven can "stop a very high percentage of bleeding episodes, 93%, with three doses or less", Novo said. However, a few patients developed anti-drug antibodies to the new treatment, including one with a potentially neutralising effect in one sample, and some also developed cross-binding antibodies to NovoSeven.
The company says that "none of the antibodies were inhibitory and the patients responded well to treatment during the course of the trial". However, the observation of anti-drug antibodies "and the potential risks hereof for haemophilia patients with inhibitors" has led to the discontinuation.
NovoSeven is now off-patent in certain territories but Novo still has three haemophilia drugs in Phase III which it hopes will fill the void. They are headed by turoctocog alfa which is expected to be filed on both sides of the Atlantic by the end of the year.