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[HEALTH] · EU · 13 sources

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EMA approves IcoSema weekly insulin and semaglutide combination

IcoSema type 2 diabetes EMA insulin icodec semaglutide

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorization of IcoSema. This new treatment is the first combination of weekly basal insulin icodec and weekly semaglutide designed for adults with type 2 diabetes that is not adequately controlled by diet, exercise, and oral medications.

Clinical data from the phase 3 COMBINE program, involving over 3,000 adults, indicates that the combination provides superior glycemic control compared to using basal insulin or semaglutide alone. The study also demonstrated non-inferior efficacy compared to basal-bolus insulin regimens, while showing favorable results regarding body weight and a reduction in clinically significant or severe hypoglycemia.

Medical experts, including Francesco Giorgino of the University of Bari Aldo Moro, noted that the weekly formulation simplifies therapeutic complexity. This is particularly significant for managing comorbidities such as cardiovascular, renal, and hepatic issues, as well as weight management in the growing diabetic population.

Entities

Association of Diabetologists · Committee for Medicinal Products for Human Use · European Medicines Agency · Francesco Giorgino · IcoSema · Italian Society of Diabetology · University of Bari Aldo Moro

Claims

What the coverage asserts, and how many sources carry each claim.

  • [○ 1 SOURCE] IcoSema is intended for adults with type 2 diabetes not adequately controlled by diet, exercise, and oral medications. www.doctor33.it
  • [○ 1 SOURCE] IcoSema showed favorable results regarding body weight compared to insulin regimens. www.doctor33.it
  • [○ 1 SOURCE] IcoSema achieved superior glycemic control compared to basal insulin or semaglutide alone. www.doctor33.it
  • [○ 1 SOURCE] The combination showed non-inferior efficacy compared to basal-bolus insulin regimens. www.doctor33.it
  • [○ 1 SOURCE] The COMBINE phase 3 program included studies on over 3,000 adults. www.doctor33.it
  • [● 4 SOURCES] The EMA CHMP issued a positive opinion for the weekly combination of insulin icodec and semaglutide (IcoSema). www.doctor33.it · www.technoblitz.it · lecodellitorale.it · lamilano.it
  • [○ 1 SOURCE] The combination demonstrated a reduction in clinically significant or severe hypoglycemia compared to basal-bolus therapy. www.doctor33.it

Sources

Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [www.ilsannioquotidiano.it]
Diabete tipo 2, parere positivo EMA per la combinazione settimanale icodec-semaglutide [www.doctor33.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide - EgNews OlioVinoPeperoncino - gastronomia, vino, cucina, champagne, viaggi e turismo produttori agricoli [www.egnews.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [www.forchecaudine.com]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [www.technoblitz.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [www.calabrianews.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [www.cinquecolonne.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [lecodellitorale.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [www.vetrinatv.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [www.entilocali-online.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [lamilano.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide [www.notizie.it]
Diabete, ok Ema per la prima combinazione di insulina settimanale e semaglutide - Il Quotidiano del Sud [www.quotidianodelsud.it]