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AstraZeneca (AZN) Gets CHMP Nod for Forxiga in Kidney Disease
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AstraZeneca PLC(AZN - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion, recommending the approval for its SGLT2 inhibitor, Forxiga (dapagliflozin), for a new indication. The company is seeking approval to expand the label of Forxiga for the treatment of chronic kidney disease (“CKD”) in adults with and without type-II diabetes (T2D).
Farxiga/Forxiga (Farxiga’s name in markets outside the United States) is presently approved to treat T2D and heart failure with reduced ejection fraction in several countries, including the United States and EU.
The latest CHMP opinion was based on positive results from the DAPA-CKD phase III study on Farxiga. Data from the study showed that Farxiga reduced the composite measure of worsening of renal function, end-stage kidney disease and cardiovascular or renal death, versus placebo. Per the company, if approved for CKD in Europe, Farxiga might potentially change the treatment paradigm for people with CKD.
We remind investors that in March last year, the DAPA-CKD study was stopped early on the recommendation of an independent Data Monitoring Committee based on its determination of overwhelming efficacy.
Shares of AstraZeneca have rallied 18.7% so far this year compared with the industry’s growth of 8.1%.
Image Source: Zacks Investment Research
Notably, in April 2021, the FDA approved Farxiga for the treatment of new or worsening CKD in adults with and without T2D in United States.
Several outcome studies are ongoing on Farxiga for heart failure indications and CKD indications under the DapaCare clinical program, which includes more than 35 completed and ongoing phase IIb/III studies.
Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales worth $624 million in the first quarter of 2021, up 50% year over year, reflecting steady growth across all regions. Further label expansion of the drug should drive sales in the days ahead.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s (JNJ - Free Report) Invokana, and Eli Lilly (LLY - Free Report) and Boehringer Ingelheim's Jardiance.
In a separate press release, AstraZeneca announced data from the phase II/III MEDLEY study on its vaccine candidate, nirsevimab, given to infants at high risk of respiratory syncytial virus (“RSV”) entering their first RSV season versus Synagis (palivizumab). In the study, nirsevimab demonstrated a favorable safety and tolerability profile in the given patient population.
Please note that nirsevimab is being developed by AstraZeneca and Sanofi (SNY - Free Report) as a passive immunization against RSV for all infants.
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AstraZeneca (AZN) Gets CHMP Nod for Forxiga in Kidney Disease
AstraZeneca PLC(AZN - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion, recommending the approval for its SGLT2 inhibitor, Forxiga (dapagliflozin), for a new indication. The company is seeking approval to expand the label of Forxiga for the treatment of chronic kidney disease (“CKD”) in adults with and without type-II diabetes (T2D).
Farxiga/Forxiga (Farxiga’s name in markets outside the United States) is presently approved to treat T2D and heart failure with reduced ejection fraction in several countries, including the United States and EU.
The latest CHMP opinion was based on positive results from the DAPA-CKD phase III study on Farxiga. Data from the study showed that Farxiga reduced the composite measure of worsening of renal function, end-stage kidney disease and cardiovascular or renal death, versus placebo. Per the company, if approved for CKD in Europe, Farxiga might potentially change the treatment paradigm for people with CKD.
We remind investors that in March last year, the DAPA-CKD study was stopped early on the recommendation of an independent Data Monitoring Committee based on its determination of overwhelming efficacy.
Shares of AstraZeneca have rallied 18.7% so far this year compared with the industry’s growth of 8.1%.
Notably, in April 2021, the FDA approved Farxiga for the treatment of new or worsening CKD in adults with and without T2D in United States.
Several outcome studies are ongoing on Farxiga for heart failure indications and CKD indications under the DapaCare clinical program, which includes more than 35 completed and ongoing phase IIb/III studies.
Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales worth $624 million in the first quarter of 2021, up 50% year over year, reflecting steady growth across all regions. Further label expansion of the drug should drive sales in the days ahead.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s (JNJ - Free Report) Invokana, and Eli Lilly (LLY - Free Report) and Boehringer Ingelheim's Jardiance.
In a separate press release, AstraZeneca announced data from the phase II/III MEDLEY study on its vaccine candidate, nirsevimab, given to infants at high risk of respiratory syncytial virus (“RSV”) entering their first RSV season versus Synagis (palivizumab). In the study, nirsevimab demonstrated a favorable safety and tolerability profile in the given patient population.
Please note that nirsevimab is being developed by AstraZeneca and Sanofi (SNY - Free Report) as a passive immunization against RSV for all infants.
Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
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