AstraZeneca Plc [NASDAQ: AZN] revealed that finally, it has secured the authorization of the FDA for FARXIGA. The FDA authorization is dependent on the results of the DAPA-CKD Phase III study. The positive outcome of the study encourages the firm to apply for FDA approval. Earlier, FDA has awarded the firm the priority review.
FARXIGA also known as dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, which is used to lessen the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death, and hospitalization for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression.
Shares of AstraZeneca went up 3.31% as it has gained +1.70 during the trading session of Friday. The firm has reported a trading volume of 15.29 million as compared to the average volume of 10.48 million. In the past 52-weeks of the trading session, the share of the firm fluctuated between the low range of $46.48 and the 52-week of the high range of $64.94. AstraZeneca has a total market capitalization of $142.48 billion at the time of writing.
AZN disclosed that this authorization is the greatest accomplishment for the firm. This authorization is the most substantial development in the cure of chronic kidney disease in more than 20 years. The firm has demonstrated the positive result of FARXIGA in type 2 diabetes, heart failure with decreased ejection fraction.