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  • FDA Lawsuit, Emails and Sanders

    Posted by Dawn DeBois on February 21, 2020 at 9:00 am

    It has undoubtedly been a very stressful year for some LEMS patients. FIRDAPSE gained FDA approval in January of 2019; and then, against the orphan drug act, RUZURGI gained approval in May. This made LEMS patients who had been on 3,4-DAP very happy because they got “their DAP back” (now marketed for children 17 and under, as RUZURGI). Many LEMS patients are treated with off label treatments and have been successful with gaining access to their RUZURGI again.

    The legal picture is one that some patients don’t pay attention to. We are patients and must manage our stress levels. However, Catalyst is suing the FDA over the approval of Ruzurgi that went against the Orphan Drug act. Catalyst invested millions of dollars in the clinical trials necessary to gain FDA approval for the first approved med for treating LEMS. Jacobus provided 3,4 DAP to around 200 patients for years, for free, in a compassionate use program. For those patients, it was great! For just as many patients, they couldn’t access treatment because nothing was approved by the FDA.

    What has your experience been as a patient?

    Are you on FIRDAPSE? How have you afforded it?

    Have you gotten your DAP back? How has the out of pocket cost compared to FIRDAPSE?

    How do you as a patient feel about this latest update, in the news?

    Let’s have a  respectful discussion from each patient’s point of view. How does all of this affect you personally?

    https://www.raps.org/news-and-articles/news-articles/2020/2/internal-fda-emails-reveal-how-price-sanderss-pr

    Dawn DeBois replied 4 years, 11 months ago 0 Member · 0 Replies
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