AstraZeneca PLC AZN announced that the FDA has granted a Fast Track designation to its SGLT2 inhibitor Farxiga (dapagliflozin) for reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (“CV”) death in adult patients, following an acute myocardial infarction (“MI”) or heart attack.
The blockbuster drug, approved to treat type II diabetes (T2D), will be evaluated in a phase III study, namely DAPA-MI to see its effect in adults who have suffered an acute MI. The designation is granted by the FDA based on the study’s design.
The FDA provides a Fast Track designation to help development and faster review of drugs, which treat serious and unmet medical conditions.
The drug also enjoys Fast Track designation for chronic kidney disease (“CKD”). In March, AstraZeneca stopped a phase III DAPA-CKD study evaluating Farxiga for effect on renal outcomes and CV mortality in patients suffering CKD with or without T2D earlier than expected. The decision was taken following a recommendation from an independent Data Monitoring Committee based on overwhelming efficacy. The company expects to file a regulatory application seeking a label expansion for Farxiga to include CKD patients in the second half of 2020.
Meanwhile, several label expansion studies are also ongoing on Farxiga for heart failure indications. In May, the FDA approved the label expansion of the drug as a treatment to reduce the risk of CV death and hHF in adults with HF with reduced ejection fraction (HFrEF) with and without T2D.
Shares of AstraZeneca have rallied 17.1% so far this year compared with the industry’s increase of 1.3%.
Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales of $407 million in the first quarter of 2020, representing 19% growth at constant exchange rates. Farxiga enjoys global leadership with significant market share.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s JNJ Invokana and Lilly’s LLY Jardiance, Synjardy (a) and Glyxambi). Apart from SGLT2 inhibitors, there are several other drugs being developed for similar indications which use different mechanisms. We note that a label expansion application seeking approval for Merck’s MRK vericiguat to reduce the risk of CV death in adults with HFrEF was granted priority review by the FDA earlier this week.
AstraZeneca currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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