Tysabri sBLA Filing

ELN and BIIB have followed through with their promised press release today. Apparently ELN and BIIB will be seeking to file a supplemental BLA (Biologics License Application) with the FDA in a few weeks.

Biogen Idec spokeswoman Amy Brockelman on Tuesday said the drug "never lost" its original approval from the U.S. Food and Drug Administration, although it was withdrawn from the market. She said her company and Elan now plan to submit the updated safety information on Tysabri to the FDA, as a possible prelude to re-launching the drug for treating multiple sclerosis. The data involves more than 3,000 patients with multiple sclerosis, Crohn's disease and rheumatoid arthritis that have taken Tysabri in past trials. "At this point, we do not expect we will need to conduct additional multiple sclerosis trials to return Tysabri to market," Brockelman said.

I'm glad that Biogen has assured that additional trials will not be needed to return Tysabri to the market. Some bearish analysts have been trying to argue that the FDA would require new trials before reinstating the drug. Nice call, losers. The press release had no mention on the restart of the 1808 Phase IV clinical trials, though. With the MS portion of the safety reviews finished, I really expect that a move to restart the trials will take place before filing of the supplemental BLA. The next date to look toward for possible Tysabri developments is September 28 (next week) at the ECTRIMS conference where data regarding Tysabri efficacy and safety are expected to be discussed. Shares of ELN traded at a high of $9.17 in after hours trading and closed after hours at $8.48.