2nd in world: UAE approves Inpefa drug for heart failure treatment

The Emirates Drug Establishment (EDE) announced on Monday that it has authorised Inpefa (sotagliflozin), an innovative treatment for heart failure, making the UAE the second country worldwide to approve the therapy, in yet another step reflecting the UAE’s leadership in adopting pharmaceutical innovations and strengthening its healthcare system.

Inpefa (sotagliflozin) is the first dual SGLT1 and SGLT2 inhibitor approved for the treatment of heart failure. It is an oral medication that helps regulate blood glucose levels while supporting heart and kidney health.

The treatment has been approved to reduce the risk of death from cardiovascular diseases, lower hospital admissions due to heart failure, and decrease urgent medical visits associated with the condition among adults with heart failure, type 2 diabetes, chronic kidney disease, or other cardiovascular risk factors.

Heart failure is a chronic and serious medical condition that affects the heart’s ability to pump blood efficiently, leading to advanced health complications and increased rates of hospitalisation. It represents a growing global health challenge.

Studies have shown that Inpefa (sotagliflozin) can help individuals living with heart failure or those at risk of developing it by reducing complications and lowering the risk of serious cardiovascular problems. It has also been observed that patients who begin treatment during hospitalisation start to experience its therapeutic benefits at an early stage.

Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, stressed that authorising the innovative treatment Inpefa (sotagliflozin) is part of the UAE’s commitment to adopting cutting-edge pharmaceutical innovations and reinforces its leading role in ensuring timely access to advanced and safe treatments that enhance quality of life and healthcare outcomes.

Al Kaabi added, "The Establishment attaches utmost priority to developing flexible and effective regulatory frameworks, particularly for advanced therapies. 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. This approval is a testament to our commitment to adopting global best practices in pharmaceutical regulation.”

She further stated, "We, at the Emirates Drug Establishment, are committed to developing an integrated and sustainable healthcare ecosystem built on innovation and collaboration with partners across the healthcare sector. The Establishment will continue to operate in accordance with the highest international regulatory standards to ensure the availability of specialised treatments, strengthen prevention efforts, support the sustainability of the national healthcare system, and promote community health.”

For his part, Ayman Mokhtar, Regional President of Viatris for the MENA and Eurasia region, said, "Viatris brings extensive expertise in cardiovascular care, from prevention and risk management to the treatment of complex conditions. Through our strong presence in the UAE, we are committed to making Inpefa (sotagliflozin) accessible to the patients who need it most, helping improve their quality of life."

WAM