Biogen and Elan file for Tysabri first line use in MS
pharmafile | January 18, 2013 | News story | Sales and Marketing | Biogen IDEC, EMA, Elan, FDA, MS, Tsyabri, gilenya
Biogen Idec and Elan have applied to the FDA and EMA to expand Tysabri’s use in patients with relapsing forms of MS who have tested negative to the JC virus.
If approved, the ruling could increase sales of the biotech firms’ treatment to almost $3 billion by 2015, according to analysts Berenburg, representing a 15% increased stake in the MS marketshare.
“Tysabri is an important treatment option for thousands of people living with MS,” said Hans Peter Hasler, Elan’s chief operating officer. “We are excited about these filings and the potential to make Tysabri available as a treatment option for more individuals early in the course of their disease.”
The blockbuster was taken off the market after its launch in 2004 when several cases showed patients developed a potentially fatal side effect – Progressive multifocal leukoencephalopathy (PML) – a viral infection of the brain that usually leads to death or severe disability.
But close monitoring and further risk assessment in patients along with tests, allowed the drug to rejoin the market in 2006, helped also by its efficacy in treating MS after patients stopped responding to beta interferons.
In the US Tysabri is recommended for people living with relapsing forms of MS whose disease is not responding or able to tolerate alternative therapy. In Europe it’s approved for highly active relapsing-remitting MS (RRMS) in adult patients not responding to beta interferons, or who have severe RRMS.
Injectable therapies such as Biogen’s Avonex and Merck Serono’s Rebif still make up the majority of the MS market, along with Novartis’ Gilenya. Another notable entrant is Genzyme’s Aubagio (teriflunomide), which received approval from the FDA last year.
Alfred Sandrock, senior vice president, Development Sciences and chief medical officer at Biogen said: “A first line approval would allow people with MS access to a highly efficacious treatment earlier in the course of the disease, potentially leading to better outcomes. This is an important consideration for people with MS who may want or need more efficacy.”
Brett Wells
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
