Good News in the MS world

21 January 2010 |

Several months ago I noted that Novartis and Merck KGaA were in the midst of developing the first front line oral therapies for MS. Well, now it seems that an approval of the drug is on the horizon. Novartis has filed for approval of their drug, which goes by FTY720, in the US and Europe after seeing some very promising late stage trial data come through (Merck isn't far behind, but the FDA requested retooling of the application before accepting the NDA). This oral MS market has huge potential for patients and manufacturers for a number of reasons, mainly coming from the promise of an effective MS therapy that isn't injectable.
The only potential drawback is one that should not be overlooked: an increased risk of infection that comes a result of the drugs mechanism of action. It sounds eerily similar to the PML that have plagued Tysabri, but I believe that the benefit of a pill to treat MS far outweighs the risk of infection to patients. In general, it looks like a winner...keep an eye on Novartis for the next 6 months or so...good things are likely to happen!

Here's the article from Bloomberg for more info

While Novartis was basking in the light of a promising future for its drug, SkyePharma is trying to put out the flames after the FDA rejected the NDA for its lead drug candidate, Flutiform. The asthma drug may not be completely finished though, as the FDA said that it needed additional information about the drug in the form of more clinical studies before regulatory action can be taken. I wouldn't touch SkyePharma for now...wait and see.

The company's news release here for you!

and if you're interested in flutiform...read up here

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