Emirates Drug Establishment approves Inpefa for heart failure

UAE—The United Arab Emirates has achieved another significant milestone in healthcare innovation as the Emirates Drug Establishment (EDE) announces the authorization of Inpefa (sotagliflozin), a groundbreaking treatment for heart failure.

This approval positions the UAE as only the second country worldwide to greenlight this innovative therapy, demonstrating the nation’s commitment to advancing pharmaceutical care and strengthening its healthcare infrastructure.

Inpefa represents a major advancement in cardiac care as the first dual SGLT1 and SGLT2 inhibitor approved specifically for heart failure treatment.

The oral medication works by regulating blood glucose levels while simultaneously supporting both heart and kidney health, offering patients a comprehensive approach to managing their condition.

The treatment addresses a critical medical need by reducing the risk of death from cardiovascular diseases among adults living with heart failure.

Beyond mortality reduction, Inpefa lowers hospital admissions related to heart failure and decreases the frequency of urgent medical visits associated with the condition.

The therapy benefits adults with heart failure who also have type 2 diabetes, chronic kidney disease, or other cardiovascular risk factors.

Heart failure poses a serious global health challenge as a chronic condition that impairs the heart’s ability to pump blood efficiently throughout the body.

This inefficiency leads to severe health complications and frequently requires hospitalization, placing substantial strain on healthcare systems worldwide.

Clinical studies demonstrate that Inpefa offers meaningful benefits for individuals currently living with heart failure or those at elevated risk of developing the condition.

The medication reduces complications and lowers the risk of serious cardiovascular events.

Notably, patients who begin treatment during hospitalization experience therapeutic benefits at an early stage, potentially improving their recovery trajectory.

Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, emphasized that authorizing Inpefa reflects the UAE’s dedication to embracing cutting-edge pharmaceutical innovations.

The approval reinforces the country’s leadership position in ensuring citizens receive timely access to advanced, safe treatments that enhance quality of life and improve healthcare outcomes.

Dr. Al Kaabi highlighted that the Establishment prioritizes developing flexible and effective regulatory frameworks, particularly for advanced therapies.

These frameworks enable rapid responses to urgent medical needs while enhancing the healthcare system’s capacity to manage complex and serious conditions.

She noted that this approval demonstrates their commitment to adopting global best practices in pharmaceutical regulation.

The Emirates Drug Establishment remains dedicated to building an integrated and sustainable healthcare ecosystem founded on innovation and collaboration with partners throughout the healthcare sector.

Dr. Al Kaabi affirmed that the Establishment continues operating according to the highest international regulatory standards to ensure specialized treatments remain available, strengthen prevention efforts, support national healthcare system sustainability, and promote community health.

Ayman Mokhtar, Regional President of Viatris for the MENA and Eurasia region, explained that Viatris brings extensive expertise in cardiovascular care spanning prevention, risk management, and treatment of complex conditions.

Through their strong presence in the UAE, the company commits to making Inpefa accessible to patients who need it most, helping improve their quality of life and health outcomes.