Movectro (Cladribine) withdrawn by Merck on FDA feedback

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Movectro (Cladribine) withdrawn by Merck on FDA feedback

Postby MSUK » Wed Jun 22, 2011 12:15 am

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German drugmaker Merck KGaA has given up seeking approval for its multiple sclerosis pill cladribine after U.S. drug regulators said more costly testing may be needed to allay side effect concerns.

In Australia and Russia, where cladribine is already approved and available under the trade name Movectro, Merck said it plans to withdraw the product from the market.

"Merck believes that data from ongoing clinical trials are very unlikely to address the (U.S. Food and Drug Administration's) requirements on Movectro," the company said on Wednesday, adding that conducting new trials would not justify the costs.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1629
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Re: Movectro (Cladribine) withdrawn by Merck on FDA feedback

Postby euphoniaa » Wed Jun 22, 2011 2:52 am

squiffy2 wrote:Image

German drugmaker Merck KGaA has given up seeking approval for its multiple sclerosis pill cladribine after U.S. drug regulators said more costly testing may be needed to allay side effect concerns.

In Australia and Russia, where cladribine is already approved and available under the trade name Movectro, Merck said it plans to withdraw the product from the market.

"Merck believes that data from ongoing clinical trials are very unlikely to address the (U.S. Food and Drug Administration's) requirements on Movectro," the company said on Wednesday, adding that conducting new trials would not justify the costs.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1629


And here's the rest of the (short) article:
"In March, the Food and Drug Administration (FDA) asked Merck to either provide additional analyses of study results it had submitted, or to carry out new trials.

Due to some cases of cancer that emerged during a trial, the drug had been rejected by regulators in the European uni0n, which would have been its largest market, keeping most analysts sceptical about the drug's prospects of getting FDA approval.

Merck said it will take a one-off charge of 20 million euros ($28.69 million) in the second quarter."


So...as I understand this article, oral Cladribine will no longer be an option for MS patients - anywhere - and Merck will just write it off as a failed (expensive) experiment??

It sounds like they've entirely given up on seeking approval from the U.S. and European Union, and also will remove it now from Russia & Australia, the only places it's been offered.

Or am I reading this wrong?

****Okay...this is my 4th try to edit 2 tiny typos, and the 1st 3 didn't fix a thing.

****Well, my 4th try didn't work either, but it did accept my note of explanation at the bottom.
Last edited by euphoniaa on Wed Jun 22, 2011 6:17 am, edited 5 times in total.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Postby MSUK » Wed Jun 22, 2011 2:56 am

No, you are right, it is being withdrawn worldwide.
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Postby jimmylegs » Wed Jun 22, 2011 2:39 pm

euph, i went in and tried to edit. the case change was too small a change for the editor to recognize, apparently. i had to change it to European onions and then to European Union!
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Postby brog64 » Sun Jun 26, 2011 3:26 pm

Hi,

I live in Australia and started on Cladribine earlier this month. I have been in touch with Merck and they are withdrawing the drug world wide but are in talks with the Therapeutic Goods Administration here to ensure that those of us already on the drug will be able to finish our two year course. Currently there are approximately 125 people in Australia on Cladribine but no new people will be prescribed the drug fro the 22 June.

I just hope I will be able to get my remaining doses of it.

I have only taken my initial 5 day course and am due for my second lot on 7 July. So much easier to take than the injectables. I had an awful time on all 4 of the standard DMDs with major allergic reactions to them. With Cladribine I had mild nausea the first night I took it and headaches for the rest of the week but other wise it was a doddle.

Very disappointed that it was unable to be passed by the FDA and EMA.

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