Novartis is ready to shake up the multiple sclerosis drug market, now that its Gilenya pill has the U.S. stamp of approval. It's the first oral treatment for MS approved in the U.S. and, because it's easier to use than injectable drugs, stands to steal business away from existing treatments.
Indeed, analysts are anticipating big business for Gilenya: Predictions for its peak sales now range up to $3.5 billion. That's because the FDA-approved label doesn't restrict access to the drug as much as some expected. "We were like ‘Wow,'" Helvea analyst Karl-Heinz Koch told Bloomberg. "This is a very good outcome for Novartis. They'll really be able to stir up the MS market." Koch said he now believes Gilenya can peak at almost $3 billion, rather than his previous estimate of $1.4 billion.
Potential competitors such as Biogen Idec, Merck, and Teva Pharmaceutical will be keeping a close eye on Gilenya's launch.* As the Wall Street Journal notes, Novartis doesn't have much depth in the MS field, but has been ramping up on the sales side since last year, when it took on an older MS drug.
And rivals will be fighting back. Biogen has already issued a statement pointing out that Gilenya's "long-term safety profile" hasn't yet been established and reminding everyone that the drug is covered by a risk-management plan. "We agree with the FDA that there is a need for safety monitoring for Gilenya," Biogen's release stated. Do tell.
* Editor's note: Sentence modified to remove "with IV drugs."