FDA Places Strict Warnings on Almost Approved MS Drug
Novartis Pharmaceutical’s multiple sclerosis oral drug, Gilenia (fingolimod), won FDA’s praise for being “effective”, but also recommended a special panel should look into serious side effects, including heart problems, weakened lungs and blindness. The panel, which convenes on Thursday, will advise the FDA on whether Gilenia should be approved for use in America. The FDA may or may not abide by the panel’s decision. Despite the mixed news, shares of Novartis rose on Tuesday by 27 cents.
The FDA’s biggest complaint to Novartis is that long term side effects are an unknown. All of the known side effects occurred with a few years of taking the drug. In tests, 8.5 percent of human volunteers developed serious side effects. This is nearly 3 percent more of a risk for side effects than for MS drugs currently available.
The panel advising the FDA will be made up of doctors and neurologists that are not employed by the FDA. If the panel recommends that Gilenia not be approved until long-term tests are done, then Novartis will have to spend years – perhaps decades – conducting such tests. If the drug is approved, Novartis stands to earn $7 billion per year.
Multiple sclerosis is a painful and debilitating neurological disease that previously could only be treated with a series of injections. Taking a once a day pill could be much easier for those MS patients that can still swallow. Gilenia is targeted at MS patients that had been doing better under conventional treatment but then suddenly relapse. 
why would you ever post those pictures along with this story? People with MS do not look like that. The pictures actually destroy the credibility of the story. By showing those images, the writer/publication demonstrates ignorance of the diseease and anything by the writer/publication should be not taken seriously.