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.