Alemtuzumab, an IV treatment for relapsing-remitting MS, is poised for an expedited FDA review when the current Phase III trial is completed.
The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Alemtuzumab, also known as Campath and originally developed to fight cancer, could help people with MS during the early stages of the disease.
A Phase II trial has shown that Alemtuzumab reduces the risk of relapse and accumulation of disability by over 70% compared with interferon beta in patients with early relapsing-remitting MS.
Source: Genzyme
