Just a couple of months after scoring a groundbreaking approval for its new hemophilia B drug, Biogen Idec ($BIIB) has scored another FDA OK for Eloctate, a hemophilia A drug targeting a much broader blockbuster market.
Just weeks ago Biogen posted new late-stage data on Eloctate, a factor VIII replacement regimen that targets a defective gene and offers patients prolonged circulation, demonstrating its efficacy as well as safety. Used as a prophylactic in a pediatric study, kids experienced a median annual bleeding rate of 2.0. Close to half of the subjects had no bleeding episodes to report, and 96% of the children who did experience an episode said their bleeding was controlled after one or two doses.
Biogen Idec, which partnered with Swedish Orphan Biovitrum (Sobi) on the drug, wins the development race that pitted the big biotech against Bayer and Novo Nordisk ($NVO), which have their own drugs in the clinic. A survey of analysts by Reuters came up with an average peak sales forecast of $1.5 billion.
The latest approval came through on Friday evening. Monday morning Biogen's shares were up only slightly, with analysts unsurprised by the latest success.
The pair of FDA approvals in hemophilia follows a landmark OK for Tecfidera, Biogen's new drug for multiple sclerosis that has rapidly emerged as a new standard therapy. Biogen Idec has made major progress since CEO George Scangos took the helm, effectively following up on the most promising drugs in the pipeline while establishing a dominant position in the MS market.
"The proven ability of Eloctate to provide protection from bleeding episodes with prolonged circulation marks the first significant hemophilia A treatment advance in more than 20 years," said Scangos in a statement. "As a company deeply committed to improving the lives of people with hemophilia, we are excited to bring this important innovation to those living with hemophilia A."
- here's the release