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AstraZeneca's Farxiga sNDA Gets Priority Review Status by FDA

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AstraZeneca Plc. AZN announced that the FDA accepted a supplemental new drug application (sNDA) for its SGLT2 inhibitor Farxiga (dapagliflozin) and granted priority review to the same. The sNDA was seeking approval of the drug to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) patients with reduced ejection fraction, with and without type-II diabetes (T2D).

With the FDA granting priority review to the sNDA, a decision is expected in the second quarter of 2020.

Notably, the priority review designation is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.

The blockbuster drug, approved to treat T2D, is being evaluated in two phase III studies — DAPA-HF and DELIVER — to see its effect on adults suffering from heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively.

The sNDA was based on positive results from the 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 HFrEF, who are on standard-of-care treatment, including those with and without T2D.

In September 2019, the FDA granted a Fast Track designation to Farxiga for reducing the risk of CV death or worsening of heart failure in heart failure patients.

In August 2019, the FDA granted a Fast Track designation to the same for chronic kidney disease (CKD). The drug is being evaluated in the phase III DAPA-CKD study to see its effect on renal outcomes and CV mortality in patients suffering CKD, with or without T2D.

All these studies are part of AstraZeneca's DapaCare clinical program, exploring the CV, metabolic and renal profile of Farxiga in T2D patients. The drug is also being developed to treat patients with heart failure (HFrEF and HFpEF) in the DETERMINE study.

Shares of AstraZeneca have rallied 29.1% in the past year compared with the industry’s growth of 12.1%.

Also, in August, 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 on 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.

Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales of $1.12 billion in the first nine months of 2019, representing 17% growth at constant exchange rates. 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 PLC Price

Zacks Rank & A Key Pick

AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large-cap pharma sector is Bristol-Myers Squibb Company BMY, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Bristol-Myers’ earnings per share estimates have increased from $4.33 to $4.47 for 2019 and from $5.30 to $5.78 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 8.30%, on average.

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