Connect
Brensocatib timetable to market
I recently googled Brensocatib, and found that the FDA has announced that it has a Precription Date User fee date of August 12, 2025. Now the only information I could find as to what that is, it allows the FDA can then collect money from the manufacturer (Insmed) to begin the approval process. Does anyone know if this is right? Furthermore I wonder if anyone knows possibly how long after the FDA collects their fee, would it take to get to patients with Bronchiectasis in this country and around the world. I know this is possibly the ONLY treatment specifically for Bronchiectasis, and I for one am anxious to possibly try it. Thank-you.
Like
Helpful
HugInterested in more discussions like this? Go to the MAC & Bronchiectasis Support Group.
Connect
I think you would have to work hard to find a better group than this one on Mayo Connect. What would you most like to know about Bronchiectasis today? Do you have a pulmonologist skilled in treating the condition?
Has anybody had any experience with Stem Cell therapy for MAC?
People in the support groups are saying it’s coming up for review at the end of August. They weren’t sure when it will be available if it passed the review.
There are over 35 patient support groups that meet through Zoom and some in-person. For more information, click here:
https://ntminfo.org/local-support-groups/
Please note that these groups are for people who have bronchiectasis
There are currently no approved stem cell therapies for MAC/NTM or Bronchiectasis. There is a lot of promising research underway, including for people with Cystic Fibrosis and a few other conditions, but full clinical studies can take a number of years.
Advertised Stem Cell Clinics are not offering proven, FDA approved therapies for our specific conditions, because none exist at this point. Here is what the American Lung Association has to say about stem cell therapy for lungs at this time:
https://www.lung.org/lung-health-diseases/wellness/public-health-issues-lung-health/stem-cell-therapy
The FDA maintains a current list of approved stem cell therapies:
https://ipscell.com/2025/01/updated-2025-list-of-fda-approved-cell-and-gene-therapies/
Has someone suggested to you that you have stem cell therapy?
To the best of my ability, I researched and did not find any current stem cell studies for people with NTM or Bronchiectasis.
-
Like -
Helpful -
Hug
2 ReactionsThe 90 minute webinar entitled "Updates from European BE Workshop Forum on Respiratory Tract Infections". hosted by Mary Kitlowski of RunningonAir.org and Amy Leitman of ntminfo.org. is now available on You Tube.
I plan to watch and listen to it.
I too have been following the upcoming approval of brensocatib very closely. It provided a glimmer of hope for those of us with bronchiectasis. It seems that the expedited approval may have been axed, since the drug approvals office has been put on the chopping block by the current administration. The article below is dated February 24. Does anyone have any further information on this?
https://www.prnewswire.com/news-releases/insmed-announces-that-fda-does-not-currently-plan-to-hold-advisory-committee-meeting-to-discuss-new-drug-application-for-brensocatib-in-patients-with-bronchiectasis-302382854.html
The way I read that is that that was a good sign, possibly meaning FDA liked the data they saw and did not need a meeting. Better data, fewer meetings, more efficiency?!
I know Linda Esposito follows this closely also I believe. I’m hoping that she might be able to find out how to correctly interpret what that article means. I can see how it can be interpreted either way 🤞🤞
The article states Insmed is pleased. That is a good sign.
-
Like -
Helpful -
Hug
1 Reaction