FDA accepts Teva's sNDA for Copaxone dose

A board to discuss the Multiple Sclerosis modifying drug Copaxone

FDA accepts Teva's sNDA for Copaxone dose

Postby MSUK » Mon Jun 03, 2013 6:38 am

US FDA accepts Teva's sNDA for higher concentration dose for Copaxone

Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for Copaxone (glatiramer acetate injection) 40mg/ 1mL, a higher concentration dose of Copaxone that offers a less frequent three times a week dosing regimen administered subcutaneously for patients with relapsing-remitting multiple sclerosis (RRMS). Currently, the approved dose for Copaxone is 20 mg/ 1mL, which is a once a day subcutaneous injection..... Read More - http://www.ms-uk.org/index.cfm/copaxone
MS-UK - http://www.ms-uk.org/
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Re: FDA accepts Teva's sNDA for Copaxone dose

Postby Loriyas » Mon Jun 03, 2013 9:56 am

Why won't they just change it to 20mg/1ml every other day??? (This is a rhetorical question-I know the answer!!)
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Re: FDA accepts Teva's sNDA for Copaxone dose

Postby hijeenie » Tue Jun 04, 2013 8:17 pm

Any idea if this will be accepted in Canada soon? I thought I read the original 20mg dose every other day was as effective as daily.
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Re: FDA accepts Teva's sNDA for Copaxone dose

Postby NHE » Tue Jun 04, 2013 9:56 pm

squiffy2 wrote:US FDA accepts Teva's sNDA for higher concentration dose for Copaxone


The cynical will likely view this as an attempt by Teva to pump some life back into their fading patents.
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Re: FDA accepts Teva's sNDA for Copaxone dose

Postby its2much » Sun Jul 21, 2013 11:45 am

So what will be the price of the 40mg 3 times a week? Only need 10 vials now - bet it costs more than the current 30 day 20 mg supply! (of course the 30 day supple will increase as well)
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Re: FDA accepts Teva's sNDA for Copaxone dose

Postby patticake66 » Wed Jul 24, 2013 10:44 am

My doctor has been prescribing copaxone every other day, 20mgs, for two years now. Her decision was based on 2 small studies that showed that copaxone prescribed this way is just as effective as taking it everyday. Teva is trying to hang on to the market because of Tecfidera. It wouldn't surprise me if a few years from now, Teva claims that taking copaxone once a week is just as effective as taking it everyday. It's all about the money.
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Re: FDA accepts Teva's sNDA for Copaxone dose

Postby Loriyas » Tue Jul 30, 2013 12:28 pm

I just wish this was dosed on body weight not on a one size fits all dose. It has never made sense to me that all drugs aren't dosed this way. How can a 100 pound woman and a 250 pound man be dosed the same???!!! (Sorry, just a small rant!)
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