Brensocatib FDA approval?

I'm slightly more optimistic. Keep in mind that brensocatib is a tablet, not a biologic, and has been already produced for clinical trials. Those who participated in the clinical trials, whether they were on the placebo or not, were given the opportunity to take the real drug after the trial ended. The fact that the FDA waived the requirement of a formal meeting with the decision forthcoming on August 12 makes me hope that it's fait accompli.

Almost assuredly, Insmed has prepared for commercialization and has manufacturing facilities lined up. I agree that the prior authorization and pricing, etc, might slow things down, but I suspect Insmed has a strategy for all of this. It's fun to speculate on and will be even more fun when we all get to take our first tablet! FWIW, my pulmonologist's office called me to schedule a virtual meeting on 8/19 and I doubt the timing was random. If you have not already I suggest getting on your pulmonologist's calendar!

I too scoop am optimistic on the Brensocatib, but I also understand and agree somewhat with Sue’s point of view on the medication being available for us. I can tell you BOTH this though, this is why it is so extremely nice and comforting to having you Sue & you scoop on this forum to help all of us. Your wisdom, knowledge, & experience with this topic is unmatched!!!! That includes medical professionals. And I thank you 🙏 wholeheartedly.

When I was at National Jewish Health in April, Dr. Daley told me it would likely be January at the earliest that we would have actual access to the drug.

That is the most informed and likely assessment of when Brensocatib will actually be available so thanks Jill. August would have been nice but I do not think anyone should count on that!

Yes, I agree we can be hopeful. Arikayce (also INSMED) was approved by the FDA on 9/28/18 and I received it, with full customer support, in January 2019. INSMED plans a similar rollout on their end-- at least the part that is in their control-- and I believe them.

Insmed made a financial update recently:
“Brensocatib
In February 2025, the FDA accepted the Company's New Drug Application (NDA) for brensocatib for patients with bronchiectasis, granting the application Priority Review designation with a Prescription Drug User Fee Act (PDUFA) target action date of August 12, 2025. If approved, Insmed expects to immediately launch brensocatib in the U.S.
Regulatory submissions for brensocatib in Europe and the United Kingdom (UK) have been accepted, with submission in Japan planned for the second half of 2025. Insmed anticipates commercial launches for each territory in 2026, pending approval.
Insmed expects topline data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by the end of 2025.
The Company continues to enroll patients in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). The Company anticipates the interim futility analysis from the first 100 patients to complete Week 16 of the trial in the first quarter of 2026.”

So does this mean it might possibly be available in August??