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Brensocatib FDA approval?

MAC & Bronchiectasis | Last Active: Aug 8, 2025 | Replies (17)

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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??

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Replies to "I am curious as to why to say it will be "many months", You say it..."

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.