Promomed has received a registration certificate for Semaltara (semaglutide) in tablet form.
“This is the first and only glucagon-like peptide-1 (GLP-1) analogue available in tablet form in Russia,” the company’s press service told GxP News. “The drug’s registration is the first step toward ensuring a stable supply of this therapy and creating an alternative to the imported version, Rybelsus® (Editor’s note: by Novo Nordisk).”
Semaltara is used in the treatment of adult patients with type 2 diabetes in addition to diet and exercise. The active ingredient of the drug is an analogue of the natural hormone GLP-1, which is released after eating to help regulate carbohydrate metabolism. “The drug stimulates the production of insulin, lowers glucose levels and helps reduce body weight by controlling appetite,” the report says.
The availability of semaglutide in an oral formulation offers a choice for patients not suited to injectable therapy. The medication will be manufactured in three dosage strengths (3, 7, and 14 mg), is administered as one tablet once daily, and has storage conditions that do not include refrigeration.
The efficacy and safety of semaglutide were evaluated in eight global randomized controlled clinical trials involving 8,800 patients with type 2 diabetes. “Semaglutide demonstrated high efficacy, a favorable safety profile, and a statistically significant advantage in controlling glycated hemoglobin both in monotherapy (comparison with placebo) and in comparison with other hypoglycemic drugs,” the press service emphasized.
It was previously reported that GLP-1 agonists, including semaglutide, may be very promising in reducing alcohol dependence.
