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.