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AstraZeneca: FDA Approves Imfinzi, Farxiga DAPA-CKD Trial To Be Stopped Early

AstraZeneca plc (AZN.L,AZN) announced Monday that the U.S. Food and Drug Administration has approved Imfinzi (durvalumab) as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer or ES-SCLC. Separately, the company announced that Farxiga Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease.

Imfinzi was approved in combination with standard-of-care or SoC chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide).

The approval was based on positive results from the Phase III CASPIAN trial showing Imfinzi in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival versus SoC alone.

The Phase III CASPIAN trial had two primary endpoints comparing experimental arms to SoC. In the Imfinzi plus SoC arm, the risk of death was reduced by 27%.

The second experimental arm testing tremelimumab added to Imfinzi and SoC recently completed, but did not meet its primary endpoint.

Imfinzi received its first approval based on the Phase III CASPIAN trial in Singapore for patients with ES-SCLC in February 2020.

Regarding Farxiga, the company said it is the first SGLT2 inhibitor to show meaningful benefit in patients with chronic kidney disease in a trial including both type-2 diabetics and non-diabetics

The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease or DAPA-CKD Phase III trial for Farxiga (dapagliflozin) in patients with chronic kidney disease or CKD will be stopped early following a recommendation from an independent Data Monitoring Committee based on its determination of overwhelming efficacy.

The decision to stop the trial early was made following a routine assessment of efficacy and safety which showed Farxiga's benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial.

In August 2019 , the FDA granted Fast Track designation for the development of Farxiga to delay the progression of renal failure and prevent CV and renal death in patients with CKD.

Farxiga is under Priority Review with the FDA and under regulatory review at the European Medicines Agency, as well as in other regions, for the treatment of patients with heart failure.

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