Insmed’s Brinsupri is the first DPP1 inhibitor approved by the FDA and the first treatment for bronchiectasis to reach the market.
The FDA has signed off on Insmed’s brensocatib, to be marketed as Brinsupri, for the daily treatment of non-cystic fibrosis bronchiectasis for adults and kids 12 years and up.
According to Insmed’s press announcement, Brinsupri’s approval marks two milestones for the industry: it is the first FDA approval for a DPP1 inhibitor and the first treatment cleared for the chronic pulmonary disorder.
“We believe today’s news sets the stage for a strong launch for Brinsupri,” analysts at Guggenheim Partners told investors in a note on Tuesday. The firm expects Brinsupri to hit some $7.3 billion in sales by 2033.
Brinsupri will cost $88,000 per year, a list price that is “a little higher” than what analysts or investors were anticipating, according to Guggenheim. The total addressable patient population for the drug in the U.S. is 500,000, according to Insmed’s announcement.
Guggenheim believes that this figure is “an underestimation,” the analysts wrote, explaining that the lack of an approved non-cystic fibrosis bronchiectasis (NFCB) drug “likely limited both patient disease awareness and physicians’ incentive to diagnose their patients with this disease.”
Brinsupri’s approval opens up a completely new therapeutic class: DPP1 inhibitors. Expressed by neutrophils, DPP1 is an enzyme that plays a role in triggering the inflammatory response in airways. Data from the Phase III ASPEN trial, published in The New England Journal of Medicine in April, showed that Brinsupri lowered the rate of pulmonary exacerbations by around 20% versus placebo. The Phase II WILLOW trial also supported Tuesday’s approval, demonstrating a roughly 40% reduction in the risk of exacerbations relative to placebo.
Given Brinsupri’s unique market niche, Insmed could, instead of partnering with a larger pharma, conceivably commercialize the asset on its own, having set launch preparations in motion in the months leading up to the approval. Last month, for instance, Insmed put some 7.81 million shares of its common stock up for sale for $96 each, expecting gross proceeds of $750 million. The company at the time explicitly noted that this money would help it with pre-launch and commercial activities for the drug.
During its first-quarter earnings report, Insmed also revealed its intent to establish a secondary manufacturing source for Brinsupri.
Insmed is also continuing to build out Brinsupri’s clinical profile beyond bronchiectasis. The biotech is also testing it for hidradenitis suppurativa, an inflammatory skin condition, and chronic rhinosinusitis without nasal polyps, both of which are in mid-stage development.
