Sanofi: smoker's lung drug benefit was swift and sustained in trial
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[May 22, 2023]
By Ludwig Burger
(Reuters) - The benefits of Sanofi and Regeneron's anti-inflammatory
drug Dupixent set in quickly during a trial to treat "smoker's lung" and
lasted for the duration of the 1-year study, French drugmaker Sanofi
said late on Sunday.
The company said it was discussing with major watchdogs across the world
whether the trial results are substantial enough to support a regulatory
review or whether that will require the results of another ongoing
trial.
It said in March in a brief summary of the late-stage trial that
Dupixent was associated with a 30% reduction in acute exacerbations of
the disease, which is also known as chronic obstructive pulmonary
disease (COPD).
This potentially added billions to the French drugmaker's growth
prospects but also underscored a heavy reliance on its bestseller.
Dupixent, approved to treat conditions including asthma and eczema, is
being jointly developed with Regeneron.
Sanofi presented details on the successful study at the American
Thoracic Society congress in Washington over the weekend.
![](http://archives.lincolndailynews.com/2023/May/22/images/ads/current/charrons_bch_2022.png)
"Within two weeks we saw improvement in lung function and improvement in
quality of life," said Naimish Patel, Sanofi head of global development
for immunology and inflammation.
"And this was also sustained, out to 52 weeks," he added.
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![](../images/052223PIX/health53.jpg)
Sanofi logo at the company's
headquarters during the annual results news conference in Paris,
France, February 4, 2022. REUTERS/Benoit Tessier
![](http://archives.lincolndailynews.com/2023/May/22/images/ads/current/longview_lda_SFARM_2023.png) A similar second COPD trial was
launched by Sanofi to underpin the statistical reliability of the
results, but it remains unclear whether regulators will start a
review now or wait for the results of the staggered second trial,
expected some time in the first half of 2024.
"We will take these results to regulators and have a discussion
about what can be done ahead of the read-out of the second trial,"
Patel said.
Sanofi previously forecast Dupixent would generate up to 13 billion
euros ($14.2 billion) in sales in its best year as it seeks to widen
its use across several inflammatory conditions, but excluded COPD
from its sales target.
Patel would not comment on any review of the peak sales estimate.
($1 = 0.9168 euros)
(Reporting by Ludwig Burger; editing by Jason Neely)
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