COFEPRIS Approves Hypertension Treatment

COFEPRIS has notified the approval of three clinical trials, 13 pharmaceutical products, and 41 medical devices. Among the approved medications is Olmesartan/Amlodipine/Hydrochlorothiazide, a treatment for patients with stage 2 primary hypertension. 

"This authorization represents a significant improvement in access to therapeutic options for the population suffering from this condition," states COFEPRIS. According to the National Health and Nutrition Survey 2024 (Ensanut) conducted by the National Institute of Public Health, 29.9% of adults in Mexico live with hypertension. 

The medication combines Olmesartan, Amlodipine, and Hydrochlorothiazide, designed for patients in stage 2 hypertension, a phase before heart attacks or strokes. According to Cardiology specialists from the National Association of Cardiologists of Mexico (ANCAM), the Expert Group on Hypertension (GREHTA), and doctors from Laboratorios Silanes, 30% of Mexican patients with hypertension (HTN) require triple pharmacological therapy to comprehensively manage their condition and achieve the necessary control levels to prevent organ damage and cardio renal metabolic syndrome. Only 50% of Mexicans with hypertension are aware of their condition, and among them, half receive medication, report specialists. 

Among COFEPRIS’ other approvals, a phase 3 study on colorectal cancer comparing amivantamab + FOLFIRI to current treatments was also greenlighted. It aims to personalize therapies and improve survival rates.

In the medical devices sector, COFEPRIS approved more than 40 products, including a non-occlusive airway dilation balloon, implant surgery systems, HPV testing kits, mechanical ventricular assist systems, and imaging equipment such as magnetic resonance and positron emission tomography (PET) scanners.