US FDA panel votes against diabetes implant due to safety concerns
Send a link to a friend
[September 22, 2023]
By Mariam Sunny
(Reuters) - A panel of external advisors to the U.S. Food and Drug
Administration voted against Intarcia Therapeutics' diabetes treatment
implant on Thursday, citing risks from potential side-effects.
The committee unanimously held that the benefits of the drug-device
combination for the treatment of type 2 diabetes did not outweigh its
risks, pointing to the need for additional safety data.
The decision comes on the back of two previous rejections by the health
regulator owing to the drug's potential acute kidney injury (AKI) and
cardiovascular risks. While the FDA usually follows the recommendations
of its expert panel, it is not obligated to do so.
In briefing documents published on Monday, the agency's staff reviewers
separately identified an "imbalance" in the number of AKI issues
reported in the treatment group, versus the placebo group.
The matchstick-sized drug-device candidate, called ITCA 650, uses a pump
that can be implanted under the skin to deliver the drug exenatide -
also the active ingredient in AstraZeneca's Bydureon - on a sustained
basis for up to a year, to treat type 2 diabetes.
When operating optimally, the device could be a game changer, said
Robert Greevy, one of the FDA panelists. However, he said the data
presented was insufficient for them to be convinced this was the best
version of the device.
[to top of second column]
|
![](../images/092223PIX/health35.jpg)
Signage is seen outside of the Food and Drug Administration (FDA)
headquarters in White Oak, Maryland, U.S., August 29, 2020.
REUTERS/Andrew Kelly/File Photo
![](http://archives.lincolndailynews.com/2023/Sep/22/images/ads/current/dare_lda_FOOTBALL_2023.png) Exenatide belongs to a class of
drugs known as GLP-1 receptor agonists, which help control blood
sugar in patients with type 2 diabetes and also work to suppress the
appetite and promote a feeling of fullness.
Originally developed to tackle diabetes, GLP-1s have gained traction
as weight-loss treatments and are in overwhelming demand in the
United States.
Intarcia, once touted as a biotech unicorn, is now a subsidiary of
privately owned i2o Therapeutics.
(Reporting by Mariam Sunny in Bengaluru; Editing by Pooja Desai)
[© 2023 Thomson Reuters. All rights
reserved.]This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.
![](http://archives.lincolndailynews.com/2023/Sep/22/images/ads/current/charrons_bch_2022.png) |