FDA accepts Novo Nordisk’s NDA for weight administration remedy

On approval, the remedy would mark the primary oral glucagon-like peptide-1 treatment for persistent weight administration. Credit score: Valente Romero/Shutterstock.

The US Meals and Drug Administration (FDA) has accepted Novo Nordisk’s new drug utility (NDA) submission for the 25 mg oral formulation of Wegovy (semaglutide) supposed for persistent weight administration in grownup overweight or chubby sufferers with a number of comorbid circumstances.

This investigational one-time-a-day therapy goals to minimise the chance of main opposed cardiovascular occasions on this inhabitants and established heart problems.

The company’s choice on the NDA is predicted within the fourth quarter of this 12 months.

The applying for Wegovy is supported by outcomes from the 64-week, managed, randomised Section III OASIS 4 trial.

This trial assessed the protection and efficacy of a 25 mg dose of oral semaglutide towards a placebo in 307 adults with out diabetes who have been both overweight or chubby with at the least one comorbidity.

The trial contributors underwent a 12-week dose escalation interval, with 64 weeks of therapy and a follow-up interval of a seven-week off-treatment.

Novo Nordisk famous that, on approval, the remedy would mark the primary oral glucagon-like peptide-1 (GLP-1) treatment for persistent weight administration.

Lately, the firm introduced that beginning July 1 of this 12 months, Wegovy would be the most popular GLP-1 receptor agonist (RA) on the template formularies of CVS Caremark, the US pharmacy profit supervisor (PBM).

Presently, the remedy is accredited as a 2.4 mg dosage injection to be used alongside a low-calorie weight loss plan and elevated bodily exercise within the grownup and paediatric inhabitants aged 12 and above with weight problems or chubby with weight-related medical issues.

Moreover, in adults with a historical past of coronary heart illness who’re both overweight or chubby, it’s used to decrease the chance of cardiovascular incidents, akin to coronary heart assaults, strokes, or mortality.

Novo Nordisk Medical Improvement, Medical & Regulatory Affairs senior vp Anna Windle stated: “We’re getting into a brand new period of weight problems care the place sufferers need individualised therapy plans that tackle their wants and supply decisions, together with oral formulations.

“We’re happy that the FDA has accepted our submission and stay up for working with regulatory authorities on what could be the primary oral GLP-1 therapy for weight problems.”

Final month, the corporate invested $1.09bn to develop its manufacturing facility in Brazil as part of the corporate’s technique to extend the manufacturing capability of its GLP-1 receptor agonist merchandise.