Sanofi plans to seek US nod for Dupixent as COPD treatment
Using Dupixent for COPD could add billions to the French drugmaker's growth prospects.
New Delhi: Sanofi plans to seek U.S. approval for it best-selling anti-inflammatory drug Dupixent to be used in the treatment of "smoker's lung", also known as COPD, after a second large trial showed significant benefits.
Sanofi, which is collaborating on the drug with Regeneron, said in a statement on Monday that a second Dupixent phase 3 trial for COPD, short for chronic obstructive pulmonary disease, showed the drug reduced exacerbations of the disease by 34 per cent.
The findings confirmed positive results from a first trial known as BOREAS earlier this year. The company had embarked on a second trial to bolster the statistical reliability of the read-outs.
It said on Monday it would file its request with the Food and Drug Administration (FDA) by the end of the year. The European Union's drug regulator is already working on a similar request based on the BOREAS data.
Using Dupixent for COPD could add billions to the French drugmaker's growth prospects. It would, however, also increase its already heavy reliance on the drug which is currently used to treat eczema, asthma and other inflammatory conditions.
Details of the second trial would be presented at an as yet undisclosed medical conference, Sanofi added.
The company has been discussing with major watchdogs across the world whether the BOREAS results were substantial enough to support a regulatory review and what role the second trial would play in reviews.
Sanofi has previously said it expects peak annual sales of Dupixent of more than 13 billion euros ($14.2 billion) but analysts have forecast on average that revenues would be well above that in 2025 and at around 18 billion euros in 2027.
Sanofi's stock plunged at the end of October, wiping 20 billion euros off its market value, after it abandoned its 2025 profit target under a plan to list its consumer healthcare business and spend more money on developing innovative drugs.
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