Prime Highlight
- The UAE has approved Inpefa (sotagliflozin)for heart failure, marking a major step in patient care for serious cardiovascular conditions.
- The drug helps reduce heart-related deaths and urgent medical visitsfor adults with heart failure, diabetes, or kidney disease.
Key Facts
- Inpefa works as a dual SGLT1 and SGLT2 inhibitor, regulating glucose in the kidneys and digestive system while supporting heart and kidney health.
- Clinical trials, including SOLOIST-WHF, showed a 33% reduction in worsening heart failure riskcompared with placebo.
Background
The United Arab Emirates has become the second country in the world to approve Inpefa, a new treatment for heart failure, marking a major step in improving care for patients with serious heart conditions.
The Emirates Drug Establishment has authorised the use of Inpefa, also known as sotagliflozin, which was developed by US-based Lexicon Pharmaceuticals. The medicine is designed for adults with heart failure, type 2 diabetes, chronic kidney disease or other cardiovascular risk factors.
According to the US Food and Drug Administration, Inpefa helps lower the risk of death from heart-related causes and reduces urgent medical visits linked to heart failure. The drug works as a dual SGLT1 and SGLT2 inhibitor, regulating glucose levels in both the kidneys and the digestive system while supporting heart and kidney health.
Heart failure remains a growing global challenge, leading to frequent hospital admissions and serious long-term complications. Studies show that patients who start Inpefa during hospital treatment begin to see benefits at an early stage.
Dr Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said the approval reflects the UAE’s commitment to adopting advanced therapies and ensuring timely access to safe and effective treatments. She said the country continues to strengthen its regulatory systems to respond quickly to urgent medical needs and improve health outcomes.
The US approval followed two large Phase 3 clinical trials that enrolled more than 12,000 patients. In the SOLOIST-WHF trial, Inpefa was associated with a 33% reduction in worsening heart failure risk compared with placebo following recent hospitalization.
In the UAE and other markets outside the US and Europe, global healthcare firm Viatris holds the exclusive licence to sell the medicine.
Ayman Mokhtar, Regional President of Viatris for MENA and Eurasia, said the company will use its strong regional presence to ensure patients in the UAE can access this important new treatment.
