The United Arab Emirates has positioned itself at the forefront of cardiovascular innovation with the groundbreaking approval of Inpefa® (sotagliflozin), becoming only the second nation globally to authorize this novel dual-mechanism heart failure treatment. The Emirates Drug Establishment (EDE) has sanctioned this oral medication that functions as a simultaneous SGLT1 and SGLT2 inhibitor, marking a significant advancement in cardiac care therapeutics.
This pharmaceutical breakthrough represents a paradigm shift in heart failure management, offering multifaceted benefits for patients grappling with this chronic condition characterized by the heart’s diminished pumping capacity. The treatment demonstrates efficacy in reducing mortality risks associated with cardiovascular diseases, decreasing hospitalization durations for heart failure episodes, and minimizing emergency medical interventions. Clinical applications extend to adult patients presenting with heart failure, type 2 diabetes, chronic kidney disease, or other cardiovascular risk factors.
Dr. Fatima Al Kaabi, Director General of the Emirates Drug Establishment, emphasized the regulatory milestone as emblematic of the UAE’s dedication to healthcare innovation. “The Establishment attaches utmost priority to developing flexible and effective regulatory frameworks, particularly for advanced therapies,” Dr. Al Kaabi stated. “Such frameworks are designed to enable rapid responses to urgent medical needs and to enhance the healthcare system’s capacity to manage complex and serious conditions.”
Medical research indicates that Inpefa® delivers particularly promising outcomes when initiated during hospitalization, with patients experiencing accelerated therapeutic benefits. The dual-inhibition mechanism addresses both glycemic control and cardiorenal protection, offering a comprehensive approach to managing interconnected health challenges.
Ayman Mokhtar, Regional President of Viatris for the MENA and Eurasia region, confirmed the company’s commitment to ensuring broad accessibility: “Through our strong presence in the UAE, we are committed to making Inpefa® accessible to the patients who need it most, helping improve their quality of life.”
This regulatory approval occurs against the backdrop of rising global heart failure prevalence, positioning the UAE as an emerging hub for medical innovation and responsive regulatory frameworks that prioritize patient access to cutting-edge treatments.