GEROPHARM’s Sejaro, an innovative medicinal product for treating obesity, has been authorised in Russia.

The new product is fully bioequivalent to Eli Lilly’s Mounjaro; however, its price will be substantially lower than that of the originator and other existing analogues.

GEROPHARM has been granted a marketing authorisation for the analogue of the American bestseller. In Russia, the originator is not approved or marketed for the indications of obesity and diabetes mellitus.

Sejaro contains tirzepatide, an innovative active ingredient that has the effects of two hormones. Its mechanism of action is dual: GLP-1 (glucagon-like peptide-1) regulates eating behaviour by reducing hunger and high-calorie food cravings, while GIP (glucose-dependent insulinotropic polypeptide) has a direct effect on fat tissues, activating lipolysis and, therefore, reducing fat deposits in the body.

The product’s efficacy in abdominal visceral obesity is especially noteworthy, given that this is the most prevalent type of obesity, where fat tissue deposits in the abdomen are the greatest. In this condition, the risk of type 2 diabetes, hypertension, and cardiovascular diseases is very high.

According to WHO, in 2022, 2.5 billion people above 18 years of age worldwide were overweight, of whom 890 mln people were obese. Since 1990, the obesity prevalence more than doubled in adults and increased more than four times in adolescents. The highest cumulative increase in obesity prevalence is observed on the Pacific and Caribbean islands, the Middle East, and North Africa.

Tirzepatide has a targeted effect on this type of fat and helps both lose weight and improve metabolic parameters. Clinical studies with tirzepatide demonstrated an unprecedented reduction in waist circumference, by 14.6 centimetres on average, and a 22.5 % weight loss within 72 weeks in people without diabetes mellitus.

Sejaro presentation is pen injectors with 6 dosages of solution for subcutaneous injection: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg. It is dosed once weekly at gradual dose escalation.

The innovative medicinal product will be marketed in May.

“Sejaro is a breakthrough in treating obesity. We are confident that this innovative product will help patients recover their health and quality of life and become an essential tool in the control of this serious epidemic,” Petr Rodionov, GEROPHARM Chief Executive Officer, said.