Novo Nordisk announced on Tuesday the launch of a 7.2 mg semaglutide injection in the US – the highest dosage of any of the company’s injectable glucagon-like peptide-1 (GLP-1) receptor agonists.
The new dosage was approved by the FDA on 19 March, reportedly providing adult patients with an additional therapeutic option and the potential for greater weight loss.
Ed Cinca, senior vice president, Marketing & Patient Solutions, Novo Nordisk, said: “We know that patients are looking for additional options for weight loss, and with [7.2 mg semaglutide] we are answering that call.”
Self-paying adults prescribed the 7.2 mg semaglutide are set to pay $399 per month, with commercially insured patients potentially paying a fraction of the price, at $25 per month, Novo said.
Prior to the recent FDA approval, the highest available dose of the injectable weight loss drug was 2.4 mg.
Martin Makary, FDA Commissioner, said: “The new FDA is moving with unprecedented efficiency on products that advance national priorities.
“[Thursday]’s approval is another demonstration of what the FDA can accomplish when we try bold new things.”
The phase 3 STEP UP trial
FDA approval of the 7.2 mg semaglutide dosage follows favourable results from the phase 3 STEP UP clinical trial. The higher dose resulted in additional average weight loss compared with previously approved doses.
At 72 weeks, adults with obesity who continued treatment with the 7.2 mg injection showed an average weight loss of approximately 21%. This value decreased to around 19%, regardless of whether patients stayed on the treatment.
Its safety profile was consistent with known side effects of semaglutide. Although, reports of altered skin sensation occurred more frequently at the higher semaglutide dosage than in lower doses but generally resolved on their own or with dose reduction. The FDA is reportedly conducting further investigations into the reaction.
Cinca said that results from the STEP UP trial show the promise that the new dose holds for patients who have not yet reached weight loss goals.
Featured image: MichaelVi on Adobe Stock
