Brensocatib FDA approval?

I am in exactly the same boat and looking forward to then 12th with great anticipation. Everything I hear (nothing official) is that it stands a very good chance of approval. How long it actually takes to get it out to us all is another matter. I am headed to Mayo Jax on the 4th and should have a slightly better handle on all that after my visit. Will try to update everyone then. PCIII

When you say they believe your inflammation is caused by high neutros, what exactly is the inflammation you experience? How high are your Neutros? I am curious because my Neutros are high but I attribute it more to infection than inflammation and wonder about the Brensocatib for my situation.

The lab my bloodwork is sent to considers the normal range 42.2 - 75.2. I think all labs differ slightly. I was always under the impression that the high neutrophils is a component of if not causing some of the inflammation in our lungs which for me causes alot more mucus for me to expel when my neutrophils are a lot higher than the normal range. Mine have been 90, and 88 at one time and I noticed much more mucus to expel and harder also. I usually run upper 70’s to low 80’s but a slight noticeable difference in easier to expel mucus. I remember hearing Dr. Charles Daly from NJH stating that 80% of patients with BE have high neutrophils in their bloodwork and he believes it is a driving force contributing to inflammation. I also believe he was basically the inventor or one of them who (along with the pharmaceutical company) developed Brensocatib. Anyone please feel free to correct me if I’m wrong. I cannot remember if I had infection during those 88 & 90 counts. But my latest neutrophil count from 4 days ago was 75.4. Below what I’ve been in the past, and I do notice a difference in the effort to do airway clearance.

I guess the whole thing about Neutrophils is still not clear to me. There are # of Neutrophils and % of Neutrophils. With your numbers I guess you are referring to %. But how do they know the elevated numbers are more from infection than inflammation.

I have the exact same questions and have asked my pulmonologist twice now about being a candidate for brensocatib. because of the high cell count of neutrophils from my recent bronchoscopy lavage and wash, to go on levaquin, even though they took over 11 ml of gunk out of my lungs, they said they could have taken more. When i do my nebulizing routine, I end up the following day doing airway clearance for 5 hours straight. Pulmonologists still say I am not a candidate for brensocatib ( these expensive medications) . I should still just do nebulizing and airway clearance daily, which I try to get done and do a 60 hr week job. I am to the point I may try and get an out of network referral to Mayo Clinic. I will follow this conversation on the brensocatib.

Everyone is anxious to get brensocatib. My gut feeling is that it will be many months before it is 1) available to the public in any quantity and 2) on the formulary for any health insurance (with whatever restrictions they will impose).

As it is rolled out and more people begin to use it we will also learn a LOT more about it's effectiveness, long-term side effects and interactions with other meds.

So while I am hopeful that it will help some of us, I don't think it will be the answer for everyone.

Your mucus situation sounds so very similar to mine!!! I know both of the pulmonologists that I’ve mentioned have said the worst of my BE is in my left & right lower lobes with the left being slightly worse. And in my right middle lobes. I’ve come to almost believe that no matter how hard, how diligent, or perfect we do our airway clearance we will never get it all especially if in the lower lobes. It’s just to deep and gets to impacted for the bronchodilator and/or hypertonic saline to penetrate to help. I just can’t believe that some pulmonologist don’t understand that, and I’ve heard some have even said, if you do airway clearance right, you should be clear all day. It just frustrates me when some doctors don’t seem to believe how their patients feel. I wish there would be RRT’s available to show us how to do it right!!! I’ve had to learn most of my ACT from social media you tube, this forum, webinars

Do they tell you why you are not a candidate??

I am curious as to why to say it will be "many months", You say it is your "gut feeling". Do you have some facts behind that which might be helpful for us??

Sure.
Drug companies do not "ramp up" production until they get the final FDA approval, especially on biologics that cost a fortune to produce and have a limited shelf life. So there is lag time before there is product in the marketplace. And even more time while decisions are being made by the pharmacies whether they will carry it - as a drug for a rare condition, expect it to be only available through limited outlets.

Next you need an appointment with your pulmonologist to get prescribed. And he has to have received information from the manufacturer on guidelines for prescribing (not yet published).

Then look at the drug formulary for your health insurance - you will see that Brensocatib is not there, meaning your insurance company will reject coverage until they have the "prior approval" dance with your doctor.

Optimistically next January for the first two issues?

Formularies for 2026 are being established now, so probably 2027 for that. Even then, they will require a lot of "proof of necessity". In the meantime, they may just deny it or require a lot of work from you and your care team.

Probably the first places to have it available for dispensing will be NJH and other Bronchiectasis Centers. And it may be expensive to the patient - although I expect the manufacturer may offer cost-sharing.