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FDA grants fast track designation to dapagliflozin for worsening heart failure
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The FDA has granted fast track designation to the SGLT2 inhibitor dapagliflozin for reducing the risk for cardiovascular death or worsening heart failure among adults with heart failure with reduced or preserved ejection fraction, according to a press release from AstraZeneca.
The FDA’s decision marks the second fast track designation for the diabetes drug in 4 weeks. In August, the agency granted fast track designation to dapagliflozin (Farxiga) for treatment of patients with or without diabetes who have chronic kidney disease to delay progression of renal failure and to prevent CV and renal death.
Fast track is a designation of a drug for expedited review to facilitate the development of drugs that treat a serious or life-threatening condition and fill an unmet medical need, according to the FDA.
“Heart failure affects approximately 64 million people worldwide, and about half will die within 5 years of diagnosis,” Mene Pangalos, executive vice president of biopharmaceuticals research and development for AstraZeneca, said in the release. “This fast track designation for Farxiga brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore Farxiga as a potential new treatment option for heart failure patients.”
The fast track designation is based on two phase 2 trials, DAPA-HF and DELIVER, which investigated the role of dapagliflozin in patients with HF with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively. Data presented in August at the European Society of Cardiology Congress and reported by Healio demonstrated that treatment with dapagliflozin reduced risk for worsening HF and CV death when added to standard therapy for patients with HF, with and without diabetes.
New data from several large CV outcomes trials have revealed that SGLT2 inhibitors as a class demonstrate a consistent reduction of HF events among adults with type 2 diabetes, and several dedicated HF trials with SGLT2 inhibitors are currently underway to examine their ability to treat existing HF. The EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies, will evaluate the effect of empagliflozin (Jardiance, Boehringer Ingelheim) on CV death and hospitalization for HF among adults with chronic HFrEF or HFpEF, respectively, according to a press release from Boehringer Ingelheim. SOLOIST-WHF will assess the effect of sotagliflozin (Sanofi/Lexicon) on CV events among people with type 2 diabetes following worsening HF, according to a press release.
Dapagliflozin is approved as a monotherapy and as part of combination therapy to improve glycemic control in adults with type 2 diabetes. In February, the FDA approved an expanded indication for the medication for treatment of patients with type 2 diabetes and moderate renal impairment with an estimated glomerular filtration rate of at least 45 mL/min/1.73 m². – by Regina Schaffer
Disclosure: Pangalos is executive vice president, BioPharmaceuticals R&D at AstraZeneca.