TPP Product X in PPMS DRAFT AND HYPOTHETICAL INFORMATION FOR MARKET RESEARCH THESE PRODUCTS ARE NOT CURRENTLY EMA or FDA APPROVED FOR ANY NEUROLOGIC CONDITION Attribute
Product X
Mechanism of action
Humanized monoclonal antibody that selectively targets B cells, binding to CD20 antigen
Indication(s)
Primary Progressive Multiple Sclerosis (PPMS) in adults
Attribute
Data from a double-blind controlled trial of PPMS patients (~700 patients), where all patients had received at least 120 weeks of either product X or placebo, showed the following: Primary endpoint
Primary Efficacy Endpoint & Additional Supporting Efficacy Endpoints
Product X PPMS indication
Confirmed disability progression for at least 12 weeks Relative reduction vs placebo
Confirmed disability progression at 24 for at least weeks
Secondary endpoints
Relative reduction vs placebo
Time required to walk 25 feet (Timed 25-Foot Walk, or T25-FW) Relative reduction vs placebo
Reduction in the volume of T2 lesions Relative reduction vs placebo
Reduced rate of whole brain volume loss Relative reduction vs placebo
Safety & tolerability
Dosing
24% p=0.0321
25% p = 0.0365 29% p=0.0404
3% vs an increase for placebo of 7% p < 0.0001
18% p=0.0206
• •
0.2% withdrawals due to IRRs at first infusion Similar risk of serious infections vs. placebo at 120 weeks
•
PML risk unknown; no cases of PML were reported in clinical trials, however PML has occurred in patients treated with other antibodies with a similar mechanism of action; a risk of PML cannot be ruled out
IV once every 6 months; 4 hour infusion time (minimum 1 hour monitoring at infusion)