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Multiple Sclerosis: Update Bulletin # 1 [February 2019]

Product Code:
Publication Date:
February 2019

This edition presents the views and insights from three world leading key opinion leaders (KOLs) from North America and Europe on a variety of recent events in the multiple sclerosis (MS) market, including: Initiation of Biogen’s Phase IIIb extended interval dosing trial (NOVA) with Tysabri (natalizumab)in people with relapsing-remitting MS; the issuing of an FDA warning about risk of disease worsening after stopping Novartis’ Gilenya (fingolimod) treatment; the FDA acceptance of an Investigational New Drug (IND) application to initiate a Phase II clinical trial of BrainStorm Cell Therapeutics’ NurOwn, an autologous cell-based approach, for the treatment of progressive MS.

Business Questions:

• What is the rationale behind the extended interval dosing trial with Tysabri?
• Do KOLs expect Tysabri’s efficacy to be maintained after 6 weeks?
• What impact will positive results have on current treatment practices?
• How concerned are KOLs about the FDA warning of risk of disease worsening after stopping Gilenya treatment?
• Will the warning significantly impact Gilenya usage?
• Could the newer sphingosine modulators also be subject to the same risks, and how could this be managed?
• Do KOLs see a use for BrainStorm Cell Therapeutics’ NurOwn in progressive MS?
• What hurdles face the use of mesenchymal stem cell therapy?
• Where will NurOwn be best positioned in the treatment paradigm?


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