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. …
“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.” …
… 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?”
“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:
I am shocked (in a negative meaning)
Maybe Biogen bite back for FDA peoples petitition……as first line tysabri will eat into the profits of glaterimer acetate.
Let's hope so; if Tysabri was available first-line who would want to risk a poor response to copaxone or the interferons. Every relapse is one relapse too many.
Here's a comment I posted in 2007 on an email group for parents of young MSers. That is what I still think."If Tysabri is proven to be the most effective of the meds, and if safety issues are taken care of, why should it remain the last choice treatment?The most effective treatment should be the first choice if possible."
from Anon 6:50:00 am again:Safety issues are not fully 'taken care of', because anybody can turn JCV+ at any time.Despite that, I still feel Natalizumab should be available as a first-line treatment to those who want it.
The question is to what extent safety issues can be taken care of with Tysabri. As far as I understand, people can pick up the jcv virus at any time – so you could test negative to it, go on Ty and then pick up the virus – and the problem with the side effects that ensue then is that they are extremely grave / likely terminal. To me the space to really watch is Fingolimod/Gilenya (which I am on as second line treatment after failing on betaferone (allergy) and not doing as well as I could on Copaxone) and some of the new treatments now in the pipeline which seem to be effective but so far seem to have potential side effects that tend to be less grave than tysabri. Something like a overworked liver has more hope for treatment than irreversible brain damage. To summarize – I'd answer your rhetoric question re. kidding yourself with "yes" and must admit that I was really rather shocked by the Tysabri announcement. It seems the drug producers are all launching into a panic as they fight for their percentages of the market.
I also have a feeling that it's now a pharma war breaking out and safety issues are put aside in favour of money politics. I also don't find it convincing to say BG-12 is dangerous and then present Tysabri as the new 'safer' drug…? I would not take Tysabri if I were newly diagnosed that's for sure but opt for the newer tablets or Gilenya (which probably is now the winning third party if Teva and Biogen start to block each other's profits).
pharma war..hand bags at five paces? What we need is a price war.. and get the costs of drugs down.