(RxWiki News) It can be a long and tiring process to get a drug approved by the FDA. Sometimes, drug companies can make changes so that their drug gets the go-ahead. In other cases, the company will simply give up.
That is what happened recently with the company Merck KGaA and its efforts to get Litak (cladribine) approved for treating patients with multiple sclerosis (MS).
In light of feedback from the FDA, Merck announced that it would no longer try to gain worldwide approval for cladribine tablets for treating relapsing-remitting MS - the most common type of MS. In a statement, the company wrote that findings from studies going on right now are not likely to meet the FDA requirements.
"Merck has stopped seeking FDA approval for an MS drug."
According to Dr. Stefan Oschmann, member of Merck's Executive Board and head of the Merck Serono division, the company has decided to not continue with the worldwide approval process for a few reasons.
First, it would take too long to start a new clinical trial program. Second, even if Merck had the time to start a new trial, there is the possibility that the results would still not be enough to get FDA approval. This would cost the company without any benefits. Third, the drug market is highly competitive and the business risks involved with continuing the approval process are too high.
Instead of carrying on with cladribine, Oschmann explains, Merck will return its focus to its other MS drugs in order to look out for the health of patients with this crippling disease.
In addition to stopping efforts to gain worldwide approval, Merck also plans to take cladribine off the market in Australia and Russia - where the drug is already approved under the trade name Movectro.