First drug to treat bronchiectasis lung condition approved by FDA
For the first time, people with bronchiectasis will have a treatment option.
The U.S. Food and Drug Administration has approved Insmed's daily pill brensocatib, which will be sold under the brand name Brinsupri.
The drug is designed to treat non-cystic fibrosis bronchiectasis, a chronic condition that damages the lungs and makes it harder to clear mucus, the company said in a statement.
The approval comes after the medication succeeded in one of last year's most closely watched Phase 3 clinical trials. The company says Brinsupri could become a blockbuster, estimating peak sales at $5 billion a year, STAT News reported.
"The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed," the company's chief medical officer, Dr. Martina Flammer, said in a statement.
The American Lung Association estimates that bronchiectasis affects between 350,000 and 500,000 adults in the United States.
It happens when the airways in the lungs become widened, thickened and scarred - often after an infection or other damage. This makes it difficult to clear mucus, allowing germs and particles to build up and cause repeated lung infections.
Brinsupri works by blocking an enzyme called DPP1. Insmed bought the drug from AstraZeneca for $30 million and is also testing it for other conditions, such as chronic rhinosinusitis, STAT News reported.
The company plans to sell the drug in the U.S. at an annual list price of $88,000. It has also filed for approval in Europe and the United Kingdom, and it plans to do so in Japan.
"For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Based on the strength of the data and the impact we've seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care." Dr. Doreen Addrizzo-Harris, a pulmonary and critical care physician and director of the NYU Langone Health Bronchiectasis and NTM Program in New York City, said in a news release.
More information
The American Lung Association has more about bronchiectasis.
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