(RTTNews) – Novo Nordisk introduced that the US Meals and Drug Administration has permitted Rybelsus—the one oral GLP-1 remedy—for decreasing the chance of main hostile cardiovascular occasions (MACE), together with cardiovascular loss of life, coronary heart assault, and stroke, in adults with sort 2 diabetes who’re at excessive threat, no matter prior cardiovascular historical past (protecting each major and secondary prevention). Outcomes from the SOUL trial additional reinforce the scientific profile of semaglutide, a molecule studied throughout a number of therapeutic areas.
This new indication makes Rybelsus the one oral GLP-1 medication permitted to scale back the chance of MACE in adults with sort 2 diabetes who’re at excessive threat for these occasions. It serves for each major prevention (decreasing the chance of main hostile cardiovascular occasions by stopping or managing threat components in adults who’re at excessive threat for these occasions) and secondary prevention (decreasing the chance of one other occasion in individuals who have had a severe CV occasion).
The FDA initially permitted Rybelsus in 2019 as the primary and solely GLP-1 medication in tablet type, together with food regimen and train, to enhance glycemic management for adults with sort 2 diabetes.
Individually, Novo Nordisk has additionally submitted a supplemental software within the US for a once-daily oral formulation of semaglutide beneath the commerce title Wegovy for the remedy of weight problems. A choice is anticipated later this yr.
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