The Cladribine Multiple Sclerosis pill to be known as Mylinax is approved for use in the US for treating forms of blood cell cancer under the brand name Leustatin.  But while approved in some countries, Cladribine MS use in the states has met repeated rejection by the FDA.  The reason so many patients are excited about Cladribine Multiple Sclerosis approval is that it will be in the form of a pill.  There is still no cure for MS, but a lot of research is being conducted to focus on easing the symptoms and slowing the disability.  There are estimate that over two million patients worldwide suffer from MS, most from the relapsing-remitting form of the disease. If approval is won in the US for Cladribine, Multiple Sclerosis would certainly celebrate, but Merck would stand to gain financially in a substantial way as well.  So they are not about to give up yet

 

The Cladribine Multiple Sclerosis pill claims to reduce relapses and reduce disability by 30 to 40 percent.

 

MS cruelly turns the body’s own immune system against itself. This causes inflammation, which is the primary cause of the disease’s debilitating symptoms. Cladribine MS treatment is said to suppress the immune system, primarily by depleting the T-cells (white blood cells that cause inflammation).  Also attractive is that the Cladribine Multiple Sclerosis pill would only have to be taken between eight and twenty times annually. Most of the current research being conducted to satisfy the FDA is being done in England, at the London School of Medicine and Dentistry and is still being funded by Merck. Even if the Cladribine MS pill becomes approved, the cost could be prohibitive, and the side effects will have to part of the decision process as well.

 

Priority review status granted by FDA

 

The U.S. Food and Drug Administration granted Priority Review status to the application to approve the Cladribine Multiple Sclerosis pill. The administration gives this status to drugs that they feel offer major treatment advances. The goal for Priority Review completion is six months from the applications submission. But it usually takes longer. The promise of significantly improving the relapse rates, as well as the uniqueness of an  oral form of treatment were major considerations for the Priority Review status. Fingolimod was granted similar status earlier and is still not approved, although it is reported to be close and is in the final review state. Stay tuned.