A newly authorised heart failure treatment is set to reach patients in the UAE after regulators cleared a therapy that targets both blood sugar control and cardiovascular function, marking another milestone in the country’s drug approval record.
According to Gulf News, the Emirates Drug Establishment (EDE) confirmed on Monday that it has approved Inpefa® (sotagliflozin), positioning the UAE as only the second country globally to allow the medication’s use. The authorisation covers adult patients with heart failure who may also have type 2 diabetes, chronic kidney disease, or other cardiovascular risk factors.
Inpefa® is notable for being the first approved medication that works as a dual SGLT1 and SGLT2 inhibitor. Taken orally, it acts on glucose absorption and excretion while also offering protective effects for the heart and kidneys. Regulators said the drug is intended to cut the likelihood of cardiovascular-related deaths, reduce hospital admissions linked to heart failure, and lower the need for urgent medical care.
Heart failure remains a long-term and progressive condition in which the heart cannot pump blood efficiently, often leading to repeated hospitalisation and serious complications. Health authorities have identified it as an increasing burden on healthcare systems worldwide.
EDE cited clinical findings showing that sotagliflozin can lessen complications among people already living with heart failure as well as those at high risk of developing the condition. The data also indicated that patients who begin the therapy while hospitalised may experience clinical benefits earlier in their treatment course.
Commenting on the decision, EDE Director General Dr Fatima Al Kaabi said the approval reflects the UAE’s broader strategy to keep pace with advanced pharmaceutical developments and ensure timely patient access to new therapies.
“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 said.
She added that the authority is focused on building “an integrated and sustainable healthcare ecosystem built on innovation and collaboration with partners across the healthcare sector,” while maintaining international regulatory standards.
From the industry side, Ayman Mokhtar, Regional President of Viatris for the MENA and Eurasia region, said the company aims to make the newly approved therapy available to patients in the UAE who stand to benefit from it. “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,” he said.
