Will natalizumab get a first-line license?

Yahoo Finance. Biogen Idec and Elan submit applications for first-Line Use of natalizumab in anti-JCV antibody negative patients with MS. 16th Jan 2013

... Biogen-Idec and Elan Corporation, have announced that they have submitted applications to the FDA and EMA requesting updates to the US and European labels for natalizumab. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of MS who have tested negative for antibodies to the JC virus (JCV). A formal assessment of both applications is ongoing. ...

... These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering treatment with natalizumab. If approved, a first-line label will allow all appropriate anti-JCV antibody negative MSers to consider natalizumab early in the course of treatment, regardless of the level of disease activity or prior treatment history. 

“Our anti-JCV antibody test, STRATIFY JCV®, helps to determine the most appropriate MSers for natalizumab and the data collected to date supports our recent filing for first-line use,” said Alfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and Chief Medical Officer, Biogen Idec. “Many appropriate patients are already benefiting from natalizumab. 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.” ...

To read the full article.

"Do you think this is appropriate? Natalizumab is the most effective licensed treatment and makes a real difference to MSers with active disease. The original AFFIRM study was done in a predominantly treatment naive early MS population; these MSers did very well on therapy. Being JCV seronegative has 'derisked' the drug with regard to PML, therefore both the FDA and EMA should look favourably on these applications. Or am I kidding myself?"



CoI: multiple, I was the PI of the AFFIRM study and I am still the PI of the longterm follow-up study. We are also a recruiting site for the natalizumab in SPMS study. 

For your information the following is last month's natalizumab PML risk data:

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