Cladribine (Mylinax)
Posted: Wed Dec 03, 2008 5:36 pm
In Dignan's recent post on phase III trial end dates, he mentioned Cladribine. I talked with the nurse coordinator at the MS center near me and asked about this drug. The information I got is that that phase III trials are finishing next month (as Dignan indicated), and then they are moving into an open label extension. I got no information about the data from the trials (i.e. effectiveness).
The drug does have fast track approval from the FDA, which means that, once the drug company submits its request to the FDA, the approval process should take no longer than 6 months. So, if the data from the phase III trials looks good, the estimate on availability I got was sometime in 2009.
The drug does have fast track approval from the FDA, which means that, once the drug company submits its request to the FDA, the approval process should take no longer than 6 months. So, if the data from the phase III trials looks good, the estimate on availability I got was sometime in 2009.