Boehringer Ingelheim AIRTIVITY clinical trial

Posted by scoop @scoop, Jun 8 11:36am

Interested in more discussions like this? Go to the MAC & Bronchiectasis Support Group.

Thank you @sueinmn, and @leslie51 for your thoughts on the increasing sputum scenario with bronchiectasis. There is nothing like being heard! Sue, over the past few months after finding this site I have read your comments very carefully because you share very astute ideas based on your experiences. I have tried many of your ideas, including using the immediate acting Guaifenesin, reducing the saline percentage, keeping up with asthma medication if your doctor has deemed necessary and even cutting back on how long I am nebulizing. I will say I have tried all of them and they have helped me in small but accumulating ways. I feel like at the end of the day I am no longer having coughing fits right before bed, I feel like after a nebulizing session even though the volume is up I feel cleared and ready for a few hours without coughing. So I am very grateful for ALL your ideas. You are a godsend to this site.

@leslie51, I think I need to do a little more of what you are saying and expressing to the pulmonologist that the volume and viscosity is worrisome. Yes, I might be able to handle it but I am using every ounce of energy to pull this off leaving little time and strength for other things. I have to change my mindset to there are more things that can be done to stop or curtail this condition from progressing. Thank you for sharing your experience with us. Sharing is caring as the saying goes and this site truly is an example.

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Profile picture for crepass @crepass

I just saw these posts. The nearest trial site for me is 5 hours away, but I will talk with them in the morning by phone to see if I am candidate. I texted with my pulmonologist in New Orleans, she said I would be a good candidate, (I had a few BE exacerbations this past year) but am negative for MAC for 3 years). She also let me know that a similar medication (brensocatib) will be FDA-approved in August and I would qualify for use of this new med. We have an appt in mid-July to further discuss.
Has anyone else talked with their docs about this new med being so close to approval? I would be curious to hear all input.
Thanks,
Cindy R.

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Hi! My doctor said he wants me to try this med (brensocatib) when it comes out. He mentioned that it should be out in August hopefully.

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Profile picture for cwal @cwal

Hi! My doctor said he wants me to try this med (brensocatib) when it comes out. He mentioned that it should be out in August hopefully.

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Your doctor may be a tad optimistic about the availability date for brensocatib. Even though the FDA PDUFA (approval) date is August 12, Insmed has broadly publicized that it's commercial availability won't be prior to sometime next year in 2026.

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Profile picture for ollie4 @ollie4

Your doctor may be a tad optimistic about the availability date for brensocatib. Even though the FDA PDUFA (approval) date is August 12, Insmed has broadly publicized that it's commercial availability won't be prior to sometime next year in 2026.

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Thanks for the reality check. All the more reason to sign up for Boehringer Ingelheim AIRTIVITY clinical trial and hope we get the drug and not the placebo!

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Profile picture for ollie4 @ollie4

Your doctor may be a tad optimistic about the availability date for brensocatib. Even though the FDA PDUFA (approval) date is August 12, Insmed has broadly publicized that it's commercial availability won't be prior to sometime next year in 2026.

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Hi Ollie,
I’ve been hearing from clinicians that it’s going to be available in the fall. Would love to know if the company is saying otherwise. Do you remember your sources? Thank you, Linda Esposito

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I looked at Insmed's site and this is from an Investor News Release first qtr. It seems it depends on the country and their approval dates. In US, it looks like just after approval.
"
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 the EU and UK have been accepted, with submission in Japan planned for 2025. Insmed anticipates commercial launches for each territory in 2026, pending approval."
https://investor.insmed.com/2025-05-08-Insmed-Reports-First-Quarter-2025-Financial-Results-and-Provides-Business-Update?printable=1

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Profile picture for pacathy @pacathy

I looked at Insmed's site and this is from an Investor News Release first qtr. It seems it depends on the country and their approval dates. In US, it looks like just after approval.
"
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 the EU and UK have been accepted, with submission in Japan planned for 2025. Insmed anticipates commercial launches for each territory in 2026, pending approval."
https://investor.insmed.com/2025-05-08-Insmed-Reports-First-Quarter-2025-Financial-Results-and-Provides-Business-Update?printable=1

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“If approved, Insmed expects to immediately launch brensocatib in the U.S.”, that would mean anytime after August 12. That’s a good answer!

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Profile picture for scoop @scoop

“If approved, Insmed expects to immediately launch brensocatib in the U.S.”, that would mean anytime after August 12. That’s a good answer!

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Spoke to my pulmo July 3 and he said it will be available in August. Hope so.

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