UAE becomes second country to approve heart failure drug Inpefa

The United Arab Emirates (UAE) became the second country worldwide to approve the use of Inpefa (sotagliflozin), an innovative treatment for heart failure.

Sotagliflozin, developed by Lexicon Pharmaceuticals in the US, is a dual sodium-glucose co-transporter 1 and 2 (SGLT1/2) inhibitor used in the treatment of heart failure. In the UAE, Inpefa’s use in the UAE was authorised by the Emirates Drug Establishment (EDE).

According to the US FDA, “In patients with heart failure or those with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors, Inpefa reduced the risk of dying from cardiovascular causes and urgent medical care visit for heart failure.”

Heart failure: A global concern

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.

Treatment with Inpefa lowers hospital admissions due to heart failure, and decreases urgent medical visits associated with the condition among adults with heart failure, type 2 diabetes, chronic kidney disease, or other cardiovascular risk factors.

Studies have shown that Inpefa 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.

Inpefa is an oral inhibitor (capsule) of SGLT2 and SGLT1, two proteins responsible for glucose regulation. SGLT2 is responsible for glucose reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. While regulating blood glucose levels, it supports heart and kidney health.

Dr Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said authorising the innovative treatment is part of the UAE’s commitment to adopting cutting-edge pharmaceutical innovations and reinforces its 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.”

“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.”

Inpefa cuts heart failure risk

The FDA approval came after two randomised, double-blind, placebo-controlled Phase 3 cardiovascular outcomes studies of Inpefa in patients with heart failure or at risk of heart failure. Together, 12,000 patients were enrolled and a SOLOIST-WHF (Worsening Heart Failure) result showed that Inpefa significantly reduced risk of heart failure by 33 per cent compared to placebo in patients recently hospitalised for worsening heart failure.

In the UAE (and countries outside the United States and Europe), Viatris, a global healthcare company, has an exclusive licensing agreement with Lexicon Pharmaceuticals, for sale of sotagliflozin.

Ayman Mokhtar, Regional President of Viatris for the MENA and Eurasia region, commented: “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 accessible to the patients who need it most.”