AstraZeneca PLC AZN announced that the FDA has granted a Fast Track designation to its SGLT2 inhibitor Farxiga (dapagliflozin) for chronic kidney disease (CKD). The blockbuster drug, approved to treat type II diabetes (T2D), is being evaluated in the phase III DAPA-CKD study to see its effect on renal outcomes and cardiovascular (CV) mortality in patients suffering CKD with or without T2D.
The FDA provides a Fast Track designation to help the development and a faster review of drugs, which treat serious and unmet medical conditions.
DAPA-CKD is part of AstraZeneca’s DapaCare clinical program to explore the CV and renal profile of Farxiga in T2D patients.Apart from this study, Farxiga is being developed for treating patients with heart failure in the DAPA-HF (HFrEF), DELIVER (HFpEF) and DETERMINE (HFrEF and HFpEF) studies.
Shares of AstraZeneca have rallied 18% so far this year versus the industry’s decline of 2.8%.
Earlier this month, AstraZeneca released positive results from the landmark phase III DAPA-HF study on Farxiga. The study showed that Farxiga met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction in CV death or the worsening of heart failure compared to placebo. The study was conducted in patients with lower ejection fraction (HFrEF) on standard of care treatment including those with and without type-2 diabetes.
Also, during the same month, the European Commission approved a label expansion for Farxiga to include positive CV outcomes and renal data from the phase III DECLARE-TIMI 58 study in adults with T2D. A similar filing is under review in the United States. The DECLARE study is also part of the extensive DapaCare clinical program.
Meanwhile, last month, the FDA issued a complete response letter (CRL) to a supplemental new drug application (sNDA) for Farxiga being evaluated as an adjunct treatment to insulin for improving glycemic control in type I diabetes (T1D) patients in whom insulin shows inadequate response.
Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales of $377 million in the second quarter of 2019, representing 16% growth. Farxiga, one of the many successful new drugs in the company’s portfolio, enjoys global leadership with voluminous market share. However, during the same period, sales in the United States slowed down due to increased competition and formulary plan changes for competitors’ drugs.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s JNJ Invokana and Lilly’s LLY Jardiance, Synjardy (a fixed dose combination of Jardiance and metformin) and Glyxambi (a fixed dose combination of Jardiance and Tradjenta).
AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large cap pharma sector is Roche Holding AG RHHBY, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Roche’s earnings estimates have moved 3.7% north for 2019 and 5.3% for 2020 over the past 60 days. The stock has gained 10.9% year to date.
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