I’m currently enjoying a summer respite from some of my freelance work: HowIFightMS.com has taken a much-needed hiatus for the next few weeks and I’m relishing NOT writing or talking about multiple sclerosis. However, I leave an article below for anyone who peruses this page. It’s an update about the process for oral fingolimod getting FDA approval as the first oral disease-modifying med in the United States. Although I don’t think this drug might be appropriate for me (given some of its side-effects), I am awaiting one of the other oral meds soon to follow. Crossing fingers that some of these oral medications will replace the invasive injections/infusions that so many of us must tolerate.
Back to the beautiful weather here: today’s 80 degrees with little humidity. Might hit up the beach for the remainder of the afternoon… : )
UPDATE: FDA Panel Recommends Approval of Oral Fingolimod for Relapsing MS — If agency follows advice, it would become first oral disease-modifying therapy for MS
Updated June 14, 2010
A U.S. Food and Drug Administration advisory committee today recommended that the agency approve marketing of fingolimod capsules (formerly called Gilenia, Novartis International AG) for the treatment of relapsing multiple sclerosis. If approved, fingolimod would be the first oral disease-modifying therapy for the treatment of MS. While the FDA is not required to follow the recommendations of its advisory committees, it usually does. According to Novartis, the agency is expected to make a final decision about whether to approve the drug in September 2010.
During an all-day meeting held June 10, 2010, the FDA advisory committee reviewed data about the effectiveness and safety of fingolimod, as well as a proposed plan designed to monitor and mitigate risks – called Risk Evaluation Mitigation Strategies (REMS) that would likely be mandated to monitor safety if the agent is approved. The committee also heard public testimony from individuals and patient advocacy groups, including the National MS Society, which testified to the unmet need for more therapies for people with MS.
Among its discussions, the advisory committee recommended that fingolimod be approved at the dose (0.5 mg once daily) recommended by Novartis and that:
• Fingolimod demonstrated substantial evidence of effectiveness for the treatment of relapsing MS to reduce the frequency of clinical relapses and to delay the accumulation of physical disability;
• the safety data currently known justify the drug’s approval, and the FDA should require a post-marketing study that would proactively gather information about adverse events and longer-term safety, the effects on a broader range of people than were included in the trials, and possible complications of taking other medications including steroids along with fingolimod;
• patients should be monitored during the first dose for possible lowering of heart rate and other potential heart effects, and that some assessments for potential adverse events related to eye (especially macular edema) and lung function be required, to an extent to be determined by the FDA;
• the FDA should consider requiring a study to evaluate whether a lower dose would be as effective as the recommended dose, with fewer adverse events;
• this therapy should be approved as a first-line therapy, meaning that patients would be eligible to take fingolimod without having to try an alternative therapy first.
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