Inquiry regarding ABBV-951 -Produodopa available for patients in US with Parkinson's Disease under the Right to Try/Compassionate Use

[Canddy]

This is a follow-up post to a conversation on this site last month regarding ABBV-951 the subcutaneous dopamine pump and the lack of approval of this product in the US by the FDA - link here:

healthunlocked.com/cure-par...

I sent a medical information request to AbbVie regarding the potential use of this product under right to try/compassionate use. I connected with AbbVie today and unfortunately, there are no active trials in the US for ABBV-951, so the drug/device is not available for compassionate use (bummer).

The Medical Affairs representative confirmed that the company is going to re-submit ABBV-951 to the FDA for approval, but she did not have a timeline. She took my number and said she would get back to me with any additional information she could find out about the FDA re-submission timeline.

And so we wait...if there is any additional information regarding the timeline I will get it at the same time there is a press release about it.

[jimcaster]

That's disappointing, but thanks for the update.

[eschneid]

Thankks Canddy......Lett us knoww whenn yoou finnd ouut anythinng...

[Boscoejean]

FDA Needs to Step Up As Use of Third-Party Manufacturers Leads to Rejections

June 28, 2024 | 3 min read | Greg Slabodkin

biospace.com/fda-needs-to-s...

"While some might argue that the rise in outsourcing of manufacturing is helping biopharma companies to focus on their core capabilities, it’s also an Achilles’ heel. Out of a total of 238 CRLs issued between 2017 and 2023, 30% involved quality/manufacturing issues—particularly problems with manufacturing processes, facility inspections, or chemical, manufacturing and controls (CMC)."

[Canddy in reply to Boscoejean]

As far as I know the 3rd party that was cited in the Complete Response Letter that was issued the last time ABBV-951 (Produodopa) was rejected for approval was not involved in anything to do with ABBV-951. I think it was a ding to the company (for whatever reason).

[Rebtar]

Does anyone know what happened to Neuroderm? The differen e between the two?

[qazwsx11 in reply to Rebtar]

The NeuroDerm open label is still going. Not sure why it has not been accepted. As far as I get there’s a concern about the skin issues. Also the ND takes too many steps to complete.

[Rebtar]

Ok i found difference. Neuroderm has to use two infusion points, and cannot be monotherapy, still requires taking meds. So Abbvie seems better for the patient.

[Rebtar]

Maybe if we inundate them with inquiries they will speed things up...LOL

[Smittybear7]

thank you for sharing