The TEVA petition with the FDA

As you know TEVA has requested that licensing of new drugs are delayed until the safety of any new drug is adequately reviewed, with an effect of trying to delay BG-12 and Alemtuzumab (Lemtrada), although they are clearly aiming at the BG-12. They are claiming that it causes renal problems and also problems such as PML.

For those of you who want to read this sorry state of affairs then here is the alleged Teva letter to the FDA
(I make no warrant that it is the actual letter, but the names of the intended recipients at the FDA are familiar)
One wonders if this is really the actions of a concerned citizen or is a cynical attempt to halt the progress of BG-12, which may eat into the profits of glatiramer acetate. 

Dear Oh Dear, how low we stoop, maybe this will come back to haunt them in the future and bite them in the a**e/a*s (UK/US spelling)

Wonder what will happen next, maybe someone will request delaying licensing of drugs until marked efficacy of any new drug above placebo is shown. What could that do for re-formulation of agents past their sell-by-date i.e. past the patent life of the original. Should we be expecting more? 

Alternatively maybe they will start asking the FDA to make companies show that their new drugs actually impact on disease progression over the long term…..maybe 5 or 10 years rather than influencing just relapse rate over a few months……Yes maybe we should set the bar higher.

Well this is what you readers think about Teva’s antics!

About the author



    • No, you're probably right. Or they are people that don't have MS. Or they are MSers in the early stage of the disease and haven't yet leapt across the market chasing a solution that works for them. My neurologist is a world-reknowned MS expert, she's aggressive, I'm aggressive. It's a good fit. Neither of us are satisfied with "good enough", even though companies like Teva minimize the plight of MSers who want a new therapy, or, God forbid, a cure. That would really make Teva, well, need to change their pants.

  • Had the same thought! Funny.

    But seriously it's not a bad idea if pharma guys and doctors etc would read the blog to see how MSers think about different issues and also to read Team G's ideas – if it helps to turn minds around then it's fine.

  • Having now read the letter, there are elements that are inaccurate (only read some parts in detail because of time constraints) eg the number of people who are 'wheelchair bound' after specific lengths of time – this seems wholly inaccurate to me. Yes, it will be interesting to see how the FDA respons, do you think this type of thing happens on a regular basis?

  • The second reason for wanting restraints- that there are 'numerous effective treatments for MS currently available'- what planet are they living on?

    • Yes, especially since interferons have not shown they reduce the increase of disability. So, that leave Gilenya, Tysabri, and Copaxone. But Gilenya and Tysabri have safety risks! So, only the golden boy Copaxone remains.

      Listen, MSers like me look at the risk-to-reward relationship. I've been on Tysabri, I was JC+, there was a 1:500 risk of PML. I wouldn't fly if those were the odds of crashing, but THIS IS MY LIFE. I have to deal every waking moment with the restrictions that MS has put on me, and my choice was to try to improve and have a small chance of dying, or endure my horrible relapses and slowly decline and suffer but avoid the risk of PML. I chose the drug. It was the right call.

      Expanding the availability of new MS drugs is what MSers want, because a delay can mean that a patient does not get their drug in time to help them. This is a time-sensitive disease. We have FDA clinical trials to investigate safety among a large test population, but we shouldn't point our finger toward the outliers and throw on the brakes.

      Teva, like every company, is trying to make a profit. In exchange, they discover and bring novel therapies to patients in need. This is the system we are in. But for Teva to try to block new drugs that have passed FDA safety requirements, to withhold a therapy that promises to be an improvement on "numerous effective treatments", all to maintain their market share, is disgusting and outrageous. I truly hope that the FDA notices their obvious conflict-of-interest in this "Citizen's Appeal" and throws their stupid letter in the trash.

  • Regarding relapses as a clinical relevant endpoint the EMA seems quite sceptical. Maybe people are to bullish on BG-12/Biogen?

    " Preventing or modifying relapses. It is not clear to what extent effects on relapses are related to the prevention or delay in the long term accumulation of disability, which is a more clinically relevant effect "

    "If a product demonstrates a benefit in relapse rate or severity without an accompanying effect on preventing or delaying disability, the clinical relevance of such benefit should be justified. "

By MouseDoctor



Recent Posts

Recent Comments

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.