Insmed gains US approval of lung disease drug forecast to be blockbuster

Dive Brief:

• Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of Brinsupri to treat a chronic condition that results in dilated airways in the lungs, chronic cough and frequent respiratory infections.
• Brinsupri is the first drug to treat bronchiectasis not caused by cystic fibrosis and the first in a new class of drugs called DPP-1 inhibitors that could treat multiple inflammatory conditions. Startup Expedition Therapeutics just signed a deal with Fosun Pharma for most rights to a DPP-1 inhibitor, while Boehringer Ingelheim and Haisco Pharmaceutical Group have drugs in development.
• Wall Street analysts forecast as much as $6 billion in annual sales for Brinsupri. Insmed’s market valuation has swelled to more than $25 billion in anticipation of coming sales from Brinsupri, its other approved drug Arikayce and pipeline candidates in lung disease and Duchenne muscular dystrophy.

Dive Insight:

Known scientifically as brensocatib, Brinsupri came to Insmed as part of a 2016 deal with AstraZeneca, under which it paid $30 million upfront. At that time, AstraZeneca was seeking to “externalize” a host of non-core assets to shed costs and boost profits.

The deal has paid off for Insmed, which in testing showed Brinsupri reduced fits of coughing and shortness of breaths known as pulmonary exacerbations better than placebo, and kept them away for longer.

Insmed plans on charging $88,000 a year for Brinsupri at list price. In a presentation, the company estimated its net price would be 25% to 35% lower after accounting for rebates and discounts provided to insurers.

Bronchiectasis is often the result of tissue damage caused by infections, and affects an estimated 500,000 people in the U.S. (In cystic fibrosis, bronchiectasis can be treated by targeted drugs like Vertex Pharmaceuticals’ Kalydeco or Trikafta.)

In notes to clients Tuesday, Wall Street analysts noted how the FDA’s prescribing information puts few restrictions on Brinsupri’s use, which should enable broad adoption. For example, the agency didn’t require people with bronchiectasis have a documented number of exacerbations before becoming eligible for Brinsupri, a criteria that could have potentially limited uptake. (However, insurers may still require two or more before authorizing coverage, analysts wrote.)

The drug’s safety cautions were limited to skin and mouth side effects and use with live vaccines, which are manageable limitations, analysts added.

“The FDA label hit best-case scenario,” wrote Kelly Shi, an analyst at Jefferies, in a client note.

With Arikayce, Insmed already has a drug that’s on track to earn about $400 million in revenue this year, although the company recorded losses of $578 million through the first half of 2025. Insmed has also reported promising data for an experimental hypertension drug, and is seeking to expand the use of Arikayce and Brinsupri into other disease settings.

At nearly $26 billion Tuesday afternoon, Insmed’s market capitalization is higher than that of Biogen, Incyte, Genmab and Moderna. 

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