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Biogen’s tofersen has failed to achieve its primary endpoint in the Phase III VALOR study for amyotrophic lateral sclerosis (ALS). This setback is likely to hinder Biogen’s planned filing for United States Food and Drug Administration (FDA) approval in ALS. The company may take a similar approach as it did with its Alzheimer’s disease asset, Aduhelm (aducanumab), and still pursue an accelerated approval using some modestly encouraging data from the secondary endpoints of the trial, says GlobalData, a leading data and analytics company. Leia Mais »

Foto: Divulgação

Ana Paula Krainer irá liderar a estratégia de Marketing e Vendas de Vacinas da farmacêutica americana MSD (Merck Sharp & Dohme), ocupando o cargo de Diretora de Vacinas para o setor privado. Leia Mais »

Pela sétima vez consecutiva, o laboratório vence o Prêmio Valor Inovação, um dos principais reconhecimentos de inovação do país Leia Mais »

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At the 57th annual European Association for the Study of Diabetes (EASD) 2021 meeting, results were presented for a 3-year prospective study. The study results demonstrated that SGLT2I, either empagliflozin (Jardiance) or dapagliflozin (Farxiga), are efficacious as part of a quadruple combination therapy with metformin, dipeptidyl peptidase-4 inhibitor (DPP-4I) and glimepiride in T2D patients. Additionally, SGLT2Is are able to address the demands of the T2D market for therapies that can be prescribed in combination to address the sub-optimal HbA1c control, says GlobalData, a leading data and analytics company.

The study examined the addition of sodium glucose cotransporter 2 inhibitor (SGLT2I) to the existing triple combination therapies in type 2 diabetes (T2D) patients that continue to have sub-optimal glycemic control.

Akash Patel, Pharma Analyst at GlobalData, comments: “Key opinion leaders (KOLs) interviewed by GlobalData have expressed significant interest in identifying further possible combination therapies that include SGLT2, especially for patients who are taking a combination of therapies but are unable to achieve optimal glycemic control or have developed additional cardiorenal comorbidities.”

The trial was a single-center, three-year, open-label, prospective observational study conducted in eligible patients ages 19 years and older who had sub-optimal glycemic control (hemoglobin A1c [HbA1c] 7.5–12.0%) despite the maximum doses of metformin, DPP-4I, and glimiperide, with stable dosage for at least three months. These patients were treated with empagliflozin at 25mg per day or dapagliflozin at 10mg per day as a fourth OAD to their existing triple combination therapy, at their physician’s discretion. A total of 262 patients were enrolled, split between empagliflozin (25mg per day, n=185) and dapagliflozin (10mg per day, n-177).

The efficacy outcomes included the change in HbA1c, fasting plasma glucose (FPG), and other cardiometabolic variables at the three-year point. The safety outcomes, hypoglycemia, volume depletion, nocturia, and genitourinary tract infections (GUTIs). The mean HbA1c reduction at the three-year point was -1.7% in the empagliflozin group versus -1.1% in the dapagliflozin group (P=0.001). There was a similar trend also observed with FPG (-59.3 ± 53.3mg/dL versus -47.4 ± 61.7mg/dL for empagliflozin and dapagliflozin, respectively, P=0.055).

The trial concluded that the efficacy of SGLTIs has been sustained for three years as part of a quadruple combination therapy. Blood glucose control was achieved more often with empagliflozin (25mg per day) than with dapagliflozin (10mg per day).

Mr. Patel concludes: “With SGLT2Is demonstrating significant efficacy in the treatment of cardiorenal comorbidities and having gained FDA and EMA approval for treatment in these areas, these inhibitors will be increasingly prescribed in both triple and quadruple combination therapies across the major markets. SGLT2Is are likely to continue to increase their T2D market share and become a leading therapeutic class.”

Source: Global Data.

Após quase dois anos, a FCE Cosmetique e FCE Pharma retornam para três dias de muito conhecimento, trocas de experiências e novidades dos setores Leia Mais »