Saturday, 8 February 2014

Glatiramer acetate gets a new license

Will a three time per week Copaxone improve adherence? #MSBlog #MSResearch

Teva announced last week that the FDA has approved its new drug application for a three-times-a-week Copaxone 40mg/mL, which is a new dose. This new formulation will allow for a less frequent dosing. The old daily Copaxone 20 mg/mL will continue to be available.
 
COPAXONE (glatiramer acetate) Injection 40mg/mL

Data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study of more than 1400 patients showed that a 40 mg/mL dose of GA administered subcutaneously three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting MS.

Click here to read Teva's press release

"Is this a real innovation? Most cynics will say this is just a ploy to extend the patent protection and to protect Copaxone's market share. There are a large number of GA biosimilars on trial at the moment that are all being tested using a daily formulation. The 3x weekly formulation will keep the Barbarians or generic competition outside the gates for a few more years. The irony of this statement is that Teva is the biggest generic manufacturer in the world. In Pharma speak the 3x per week formulation is called lifecycle management. Leaving the cynicism behind for MSers on GA who are doing well having to inject yourself 3x a week will help. Fewer injections must be better. I would be interested in knowing if this would affect adherence? Paradoxically adherence may fall on the 3x per week formulation. Why? It is easier to remember a daily injection compared to 3 injections per week."

CoI: multiple

3 comments:

  1. I take GA and think that it would be much more difficult to remember 3x rather than daily. I can only think that the indenting of skin over time would be improved though...

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  2. I take GA currently, but I would be willing to switch to the new preparation to stay on Copaxone for the long term. I think a generic GA may not be the same as Copaxone because it is a complex drug. Until they prove the generics are the same as the original, I will not switch but I guess this will be determined by the bean counters at the insurance companies.

    Teva has developed a way to evaluate generics, and I think something of this nature should be used in evaluating the generics. You may say this is biased because Teva developed it but we need a way to know if generics are equivalent before being forced to switch.

    http://www.ncbi.nlm.nih.gov/pubmed/24421904

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  3. I've been on Copaxone for over a year now. No new lesions. Seeing a change from daily injections to 3 times a week sounds like a better option. Personally, i am gearing toward Tecfedera to get away from injections completely, but i want to have more children so Copaxone will most likely be my medication for a while. The daily injections aren't hard, but after a year, my upper arms are sore and the lumps don't go away as easily. Cutting down four injections would greatly improve my skin.

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