AstraZeneca gets EU approval for kidney disease drug Forxiga

(Alliance News) - AstraZeneca PLC on Monday said its Forxiga drug has been approved in the EU for ...

Alliance News 28 June, 2021 | 10:14AM
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(Alliance News) - AstraZeneca PLC on Monday said its Forxiga drug has been approved in the EU for the treatment of chronic kidney disease.

Shares in AstraZeneca were up 0.9% to 8,579.00 pence in London on Monday morning.

Chronic kidney disease affects 47 million people in the EU and 840 million worldwide, and is associated with increased risk of heart disease or stroke, AstraZeneca said. But diagnosis rates are low and most are unaware they have the disease.

Last month, the drug was approved in the US under the name Farxiga, and it is currently under review in other countries including Japan, the Cambridge-based company said.

The EU's decision was based on phase 3 trial results which showed Forxiga reduced the risk of death and had a strong safety and tolerability profile.

The drug was approved in recent months in the US, EU, China and Japan for the treatment of heart failure.

Separately, AstraZeneca and Sanofi SA on Monday announced clinical trial results for the respiratory syncytial virus drug they are co-developing, nirsevimab.

The phase 2/3 trial evaluated the safety and tolerability of nirsevimab. It showed that the drug has a similar safety and tolerability profile to another drug approved for the same disease, palivizumab.

Respiratory syncytial virus, a seasonal virus that typically circulates in autumn through spring in temperate regions, is the most common cause of lower respiratory tract infections, and the biggest cause of hospitalizations in infants worldwide.

In the trial, nirsevimab was administered to preterm infants, or those with chronic lung disease or congenital heart disease, entering their first respiratory syncytial virus season.

Sanofi shares were up 0.2% at EUR88.43 each.

"We believe nirsevimab has the potential to become an important and innovative routine immunisation for all infants - those born prematurely or at term, healthy or with health conditions," said Jean-Francois Toussaint, global head of research and development at Sanofi Pasteur.

By Ivan Edwards; ivanedwards@alliancenews.com, and Evelina Grecenko; evelinagrecenko@alliancenews.com

Copyright 2021 Alliance News Limited. All Rights Reserved.

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Securities Mentioned in Article

Security Name Price Change (%) Morningstar
Rating
AstraZeneca PLC 8,231.00
Sanofi SA 84.19

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