Novartis took a big stride toward filing for approval on an oral therapy for multiple sclerosis, revealing that a two-year, Phase III trial for FTY720 produced solid evidence of its superiority to a placebo.
Better yet, though, some analysts were quick to conclude that the data lays out a clear case that the drug is better than standard-of-care. And they were heartened to see that the low-dose pill did almost as well as the high-dose version, giving Novartis a shot at filing for an approval on the dose with the best safety profile.
FTY720 is a big player in a bold move to introduce a new generation of MS pills, with Merck KGaA also in hot pursuit of an approval. Trevor Mundel, Novartis' head of global development, told reporters that the drug had presented no new safety issues. Patients in trials have experienced skin infections, cancer and one instance of brain inflammation, but there was no firm evidence that the events were triggered by the drug. Mundel said that Novartis would file for an FDA approval by the end of the year, adding that it's possible the FDA could review the application within six months and clear the way for a commercial launch in 2010. He discounted the chances that researchers would be asked to conduct another trial.