If you’ve ever wondered how new Multiple Sclerosis drugs are developed, evaluated, and finally approved for the market, Bloomberg.com offers a link to the video of the FDA Committee Meeting on Novartis’s new Gilenia, the first pill for Multiple Sclerosis.
After drug testing and before the FDA approves a new medication, a panel of health experts considers the drug studies and, if the panel is satisfied, recommends approval to the FDA for approval. The FDA usually does as the panel suggests.
The panel reviewing Gilenia recommends it as safe and effective for controlling tremors, concentration problems and other symptoms of relapsing remitting MS.
If the medication’s side effects do not derail the FDA’s approval later this year, Gilenia will be a welcomed medication for MS patients because it is the first MS treatment available in pill form. Approval would mean no more routine injections or infusions for those who take it — no more needles or injection site reactions.
Reported side effects of Gilenia include eye disorders, heart problems and lung problems. In spite of these, the panel recommend approval of the drug for the treatment of Multiple Sclerosis.
With each medication they choose to take, MS patients are faced with the persistent question, “Will my MS treatment be worse for me than the long term effects of the disease?” Because this is a new medication, there really isn’t an answer to this question yet. Not enough people have taken it for enough time for researchers to know the long term effects.
In light of the side effects, the panel did recommend Novartis study the effectiveness of lower doses of Gilenia.
More information about Gilenia: