FDA committee unanimously recommends Novo Nordisk diabetes combo, IDegLira
pharmafile | May 25, 2016 | News story | Research and Development, Sales and Marketing | FDA, Novo Nordisk, Panel, Tresiba, Victoza, committee, ideglira, recommendation, staff
Novo Nordisk has announced that a US Food and Drug Administration (FDA) advisory committee has unanimously recommended IDegLira, a type-2 diabetes drug that combines Tresiba (insulin degludec) with the GLP-1 agonist Victoza (liraglutide).
FDA staff had previously raised doubts over perceived limitations in the clinical trial data for IDegLira. At the time, they noted: “The enhanced convenience that derives from combining two products into one dosage form generally comes at the cost of loss of dosing flexibility.”
When it came to a vote, however, the endocrinologic and metabolic drugs advisory committee voted 16-0 in favour of recommending IDegLira. The approval is based on the DUAL Phase III clinical trial, which involved more than 3,000 adults with type-2 diabetes.
The two drug combo has the potential to normalise fasting glucose and haemoglobin A1c, according to Novo. Based on the New Drug Application (NDA) submitted by Novo, the FDA asked panel members to ascertain the efficacy and safety profile of the drug.
Todd Hobbs, chief medical officer at Novo Nordisk, says: “We are extremely pleased that the advisory committee recommended unanimous approval for IDegLira and recognised that patients who require additional therapy for effective A1c control could benefit from this once-daily, single injection fixed combination treatment approach. This is an important milestone for health care providers and patients, and we look forward to working with the FDA to advance the IDegLira NDA towards approval.”
The drug combination, under the brand name Xultophy, was approved in Europe in 2014, and made available in the UK in 2015.
Sean Murray
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