Exciting News! Ocrelizumab offers Expanded Access Program

Stuart SchlossmanMultiple Sclerosis, PPMS News


                                                                  

  


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Exciting News! Ocrelizumab offers Expanded Access Program in over 50 locations for participants with Primary Progressive Multiple Sclerosis!

Ocrelizumab, which has been granted Priority Review Designation, announces expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
The primary objective of this expanded access program (EAP) is to provide ocrelizumab as treatment for eligible participants with primary progressive multiple sclerosis (PPMS) before it is commercially available in the United States (U.S.) for the indication of PPMS.
An EAP enables participants to receive an investigational medication that has not yet been approved by the United States Food and Drug Administration (FDA). This program is a nontraditional study that has no placebo group, so all those enrolled are given the active medication. It follows a strict protocol that has been developed through consultation with the FDA.

Through Ocrelizumab’s EAP, enrolled participants will receive the study medication, given every six months via two infusions, which are separated by two weeks. The study sponsor will cover the cost of program-specific medical procedures performed during this program outside the costs for standard-of-care medical procedures. Read More







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