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US FDA approves Insmed's drug as first treatment for a chronic lung disease
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US FDA approves Insmed's drug as first treatment for a chronic lung disease
Aug 12, 2025 9:41 AM

Aug 12 (Reuters) - The U.S. Food and Drug Administration

has approved Insmed's ( INSM ) oral drug for a type of lung

disease, the company said on Tuesday, making it the first

treatment for the chronic condition.

Shares of the New Jersey-based drugmaker rose 6% in

morning trade.

Insmed's ( INSM ) drug, branded as Brinsupri, targets non-cystic

fibrosis bronchiectasis, a chronic lung condition characterized

by permanently damaged airways, leading to persistent cough and

excessive mucus production.

The condition affects 350,000 to 500,000 adults in the U.S.,

according to the American Lung Association.

Brinsupri works by blocking certain inflammatory enzymes in

white blood cells, preventing them from becoming overactive and

damaging the lungs.

Earlier treatments for the condition focused on controlling

symptoms by using antibiotics, surgery or devices such as

flutter valves to clear the airways.

Insmed's ( INSM ) application was based on a late-stage trial

involving 1,680 adult and 41 adolescent patients, with the drug

significantly reducing the frequency of respiratory symptoms

such as chronic cough.

The drug was found to be safe and well-tolerated at the

two tested doses of 10 milligrams and 25 milligrams.

TD Cowen analyst Ritu Baral expects the drug to reach

peak sales of $3.7 billion in the United States by 2031.

Brinsupri has the potential to drive future profitability for

the company, she said.

Rival treatments in development for the chronic lung

condition include AstraZeneca's ( AZN ) benralizumab and

Zambon's inhaled antibiotic therapy CMS I-neb.

This marks the second FDA approval for Insmed ( INSM ) following

Arikayce, which the agency cleared in 2018 to treat a chronic

lung infection caused by bacteria commonly found in soil and

water.

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