TPP Product X in RMS 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
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Humanized monoclonal antibody that selectively targets B cells, binding to CD20 antigen
Indication(s)
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Relapsing form of MS (RMS) in adults with active disease defined by clinical or imaging features
Attribute
Data from the two 96 week Phase III controlled clinical trials of RMS patients (~800 patients per study) showed the following: Study 1
Primary endpoint
Primary Efficacy Endpoint & Additional Supporting Efficacy Endpoints
Product X RMS indication
Annualized relapse rate
IFN β-1a 0,292 46% p < 0,0001
Präp. X 0,156
Relative reduction
Confirmed disability progression at 12 weeks
Secondary endpoints
Relative reduction
Confirmed disability progression at 24 weeks Relative reduction
T1 Gd-enhancing lesions
Relative reduction
Safety & tolerability
Dosing
Präp. X 0,155
IFN β-1a 0,290
47% p < 0,0001
43% p = 0,0139
37% p = 0,0169
43% p = 0,0278
37% p = 0,0370
0,016
0,286 94% p < 0,0001
0,021
0,323
1,413 77% p < 0,0001
0,325
Relative reduction
New or enlarging T2 lesions
Study 2
0,416 95% p < 0,0001 1,904 83% p < 0,0001
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1.3% withdrawals due to IRRs at first infusion Similar risk of serious infections vs. IFN β-1a (44mcg sc x3 pw) at 96 weeks
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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
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IV once every 6 months; 4 hour infusion time (minimum 1 hour monitoring at infusion)