This was a compelling post by Akanz asking for help and requesting that everyone write letter to the FDA requesting reinstatement on the ANCHOR SPA and sNDA approval.
"I need your help ...a letter writing campaign
I have a lipid disorder ( hetero familia hypercholestremia ) , my mother had diabetes , my wife treats those on dialysis and those who have kidney disease.
Vascepa has the potential to lower the risk of heart attacks for all the diseases and disorders ( plus more ) mentioned above.
We need easy and affordable access to Vascepa WHILE WE WAIT for the results of the Reduce It Trial.
You can help by writing , faxing , email ( not sure if email will work ) some of those listed below , urging that Amarins SPA be reinstated and the Anchor indication approved for those at risk .
Vascepa is a very safe drug ...theres little to no downside from using it.
Please write / fax / email to at least the following
Dr M Hamburg FDA/OC
Dept of Heath and Human Services
200 Independence Ave SW
Washington DC 20201
Fax 301 847-3531
Email Margaret.Hamburg@fda.hhsDOTgov
Dr Curtis Rosebraugh
Director
10903 New Hampshire Ave
Silver Springs MD 20993-0002
Fax 301 796-9717
Email curtis.rosebraugh@fda.hhsDOTgov and Dr Jean-Marc Guettier ....same address but fax 301-796-9717 email jean-marc.guettier@fda.hhsDOTgov
Now is the time to act ...please do so"
My response:
Akanz,
Thank you for sharing your story. This is exactly why Vascepa should be made available for patients. Doctors and patients should have a choice. Many patients continue to have high TG levels despite being on statins and are at an increased to have heart attacks- Vascepa is clearly the best choice for these patients. It lowers TG and LDL and have much better safety profiles than other TG lowering drugs.
You have always been a very thoughtful person and written helpful messages and added insightful comments- much thanks.
I am glad to be of help and have written letter to reinstate the SPA and approve the sNDA.
I believe that the FDA recognizes that they made an error and will reinstate the SPA on 1/15.
The letters will be very helpful in letting the FDA know that the public cares about this issue.
I also urge and ask everyone to write letter to the FDA requesting the reinstatement of the ANCHOR SPA and sNDA approval- this will be very helpful in getting the ANCHOR indication approved.
Speedrunner.
FDA will be meeting this week to determine the final outcome of the ANCHOR SPA- please make your voices heard now.
