GlaxoSmithKline has won FDA approval for its new diabetes drug Tanzeum, which is injectable and will be used once a week. It will compete with Novo Nordisk’s Victoza, which is injected daily.

GSK (NYSE: GSK) announced the FDA decision on Tuesday.

The FDA review of the drug had been pushed back three months. 

GSK said that the Tanzeum (albiglutide) application with the European Medicines Agency was approved in March.

Albiglutide is a biological, injectable form of human GLP-1, a peptide that helps the body maintain normal blood-sugar levels and also helps control appetite. People who have type 2 diabetes experience reduced GLP-1 secretion in response to a meal. Albiglutide fuses human GLP-1 to human albumin, which is intended to potentially extend the duration of the drug. That means patients would need less frequent injections. Albiglutide was studied as a once-weekly injectable.

If approved, albiglutide would compete against Novo Nordisk’s blockbuster diabetes drug Victoza, a daily injectable, among other diabetes drugs. In recent tests against other diabetes treatments, albiglutide has had mixed results.

Vlad Hogenhuis, head, GSK Global Cardiovascular, Metabolic and Neurosciences Franchise, noted: “Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels. We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US.”

Approval comes after eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum.

GSK operates its North American headquarters in RTP.

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