Insmed's Brinsupri Gains FDA Approval, Marking First Treatment for Non-Cystic Fibrosis Bronchiectasis
The pharmaceutical industry witnessed a significant milestone as Insmed's Brinsupri (brensocatib) received FDA approval for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) in adults and children aged 12 and older. This landmark decision introduces the first dedicated treatment for NCFBE and marks the debut of the dipeptidyl peptidase 1 (DPP1) inhibitor class of drugs.
Breakthrough in Bronchiectasis Treatment
Brinsupri, acquired by Insmed from AstraZeneca in 2016, addresses a chronic condition affecting an estimated 500,000 people in the United States. The drug demonstrated impressive efficacy in clinical trials, with the phase 3 ASPEN study showing a 21% reduction in the annual rate of pulmonary exacerbations for patients receiving a 10 mg dose compared to placebo. The 25 mg dose group experienced a 19% reduction.
Dr. Kelly Shi, an analyst at Jefferies, noted, "The FDA label hit best-case scenario," highlighting the agency's decision not to require a documented number of exacerbations before patients become eligible for Brinsupri. This broad label is expected to facilitate widespread adoption, although insurers may still implement their own criteria for coverage.
Market Impact and Financial Projections
Wall Street analysts forecast annual sales for Brinsupri to reach up to $6 billion, with Insmed's own projections suggesting peak sales of $5 billion in the NCFBE indication. The company plans to price Brinsupri at $88,000 per year before discounts, with an expected net price 25% to 35% lower after accounting for rebates and discounts to insurers.
Insmed's market valuation has surged to over $25 billion in anticipation of Brinsupri's success, surpassing that of established pharmaceutical companies like Biogen, Incyte, Genmab, and Moderna. The company's shares have seen a fourfold increase since the release of positive phase 3 data in May 2024.
Launch Preparations and Future Outlook
Insmed has been diligently preparing for Brinsupri's launch, with its sales force engaging over 27,000 healthcare professionals in the United States since October. The company has also established a patient support team called inLighten to ensure a smooth rollout.
Looking ahead, Insmed has submitted applications for Brinsupri in the European Union and the United Kingdom, with plans to file for approval in Japan later this year. The company anticipates potential launches in these territories in 2026, subject to regulatory approvals.
As the pharmaceutical industry continues to evolve, Brinsupri's approval not only represents a significant advancement in the treatment of NCFBE but also highlights the potential of novel drug classes in addressing unmet medical needs.
References
- Insmed gains US approval of lung disease drug forecast to be blockbuster
Brinsupri, which Insmed acquired from AstraZeneca nearly a decade ago, is the first treatment for bronchiectasis that’s not caused by cystic fibrosis.
- Insmed’s Brinsupri scores landmark FDA nod in bronchiectasis, marking first approval of a DPP1 inhibitor
The FDA on Tuesday signed off on Insmed’s brensocatib to treat non-cystic fibrosis bronchiectasis (NCFBE) in adults and kids ages 12 and up. The medicine is now available by prescription in the U.S. through a specialty pharmacy network.
Explore Further
What are the specific mechanisms of action for dipeptidyl peptidase 1 (DPP1) inhibitors like Brinsupri?
Who are the key competitors in the market for non-cystic fibrosis bronchiectasis treatments and how do their products compare?
What measures can insurers implement when deciding coverage criteria for Brinsupri given the broad FDA label?
How does the projected annual sale of Brinsupri compare to existing treatments for chronic respiratory conditions?
What are the challenges Insmed might face in obtaining regulatory approval for Brinsupri in the European Union and Japan?