Label Change on Forteo (teriparatide) for those who might have missed the news from the FDA and Eli Lilly

[AnnieW55]

I have just read the information below on Inspire.com (The National Osteoporosis Foundation which is now the Bone Health & Osteoporosis) and thought it might be of some use to someone here. There was a link at the end of this which I’m not able to post right now.

“I thought it might be helpful to post the Label Change on Forteo (teriparatide) for those who might have missed the news from the FDA and Eli Lilly. We can now take it beyond the two year limit that was originally on it from the manufacturer and the FDA. This is a good explanation on the things that changed and why they felt it necessary to publish this and extend it's usage. To be able to take this beyond the original two years you do need to be at high-risk of fracture and continuing low T scores.”

Admin: If this is not an appropriate post please delete.

[Pinklady19]

That’s good information my endocrinologist already wants me to take forteo for two years. I’m hoping the forteo works for me!

[Hidden]

Thank you for posting this info. I recently heard about the change for Forteo. I used Tymlos for 2 years - hopefully it too will be approved for longer use at some point. There is a desperate need for more bone formation therapies for those of us with severe osteoporosis (and multiple fragility fractures). Hoping that more therapies are in the pipeline but from what I understand, it is quite difficult for potential osteoporosis treatments to meet the clinical trial endpoint outcomes required (no fractures) in a population at high risk of fracturing to begin with.

[Mark_ABH in reply to Hidden]

I can tell you there is an oral medicine in the pipeline that works like Tymlos and Forteo (both of which are taken by injection). The maker has been able to move ahead in the FDA process by showing improvement in bone mineral density, not fracture risk, which is a very significant change. That could help more osteoporosis treatments come to market. It is difficult to show change in fracture risk because you need large populations and long time frames.

investors.enterabio.com/new...

[Hidden in reply to Mark_ABH]

Thanks for the link with info. That is promising that this potential treatment is moving forward with a different PhaseIII endpoint outcome requirement. Hopefully there will be more progress in osteoporosis treatments now. I didn't have a great response with Tymlos so not sure a Forteo type oral drug would work any better for me personally. I certainly will be watching for updates. I have only 6 months remaining in my Evenity treatment and I am dreading the other options based on my personal factors.

[Mark_ABH]

Thank you for the heads-up! American Bone Health will need to update our info on FDA-approved treatments.