A combined type 2 diabetes drug which will half the number of injections users need has been recommended for approval in the US.
The drug is called IDegLira, which has already been approved in the UK as Xultophy. It is manufactured by Novo Nordisk and combines Tresiba (insulin degludec) with its GLP-1 agonist Victoza (liraglutide) in one fixed dose. Both of these are existing Novo Nordisk drugs.
The Endocrinologic and Metabolic Drug Advisory Committee voted unanimously that the US Food and Drug Administration (FDA) should allow IDegLira to be used by people with type 2 diabetes.
Clinical trials showed the drug, which can be administered using just one injection instead of two, can help people control their blood sugar better.
Todd Hobbs, Novo Nordisk’s chief medical officer in the US, said: “We are extremely pleased that the advisory committee recommended unanimous approval for IDegLira and recognised that patients who require additional therapy for effective HbA1c control could benefit from this once-daily, single injection fixed combination treatment approach.”
In the drug report the panel wrote: “IDegLira provides important treatment benefits by enabling the administration of both IDeg and liraglutide in one single injection at any time of the day via a convenient, pre-filled pen.
“The availability of this combination product could remove uncertainties for many patients and caregivers with respect to managing initiation of basal insulin + GLP-1 RA combination therapy, including dose adjustment of the two drugs during both initiation/transfer and maintenance phases.”
If approval is granted for the drug, it would be the first product to provide people in the US with a better way to control blood sugar while also eliminating some of the complications associated with insulin use in one dose.
The FDA had expressed concern that the drug performed well in the trials because of the way they had been designed.
FDA advisory committees are compiled of independent experts whose role is to advise on specific questions which may be raised by the organisation as it considers regulatory decisions.
The panel’s recommendations are not binding, but the FDA does take its advice into consideration when drug applications are being reviewed.
