Shots: The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose of single 600mg infusions were administered over a shorter, 2hrs. […]Read More
Shots: Roche divulges new data that demonstrate Ocrevus (ocrelizumab) is a highly effective treatment option for people with RRMS who experienced a suboptimal response to their prior DMT. In open-label P-IIIb CASTING study, 75% of patients with RRMS and suboptimal response to prior treatment had no evidence of disease activity 2yrs. after switching to Ocrevus […]Read More
Shots: Roche has initiated the P-III program for fenebrutinib (BTK inhibitor) in RMS and PPMS which include two identical P-III trials in RMS (FENhance 1& FENhance 2) and one P-III trial in PPMS (named FENtrepid). The studies target clinical disability progression and have a 1EPs of 12wks. cCDP-12, with the addition of a co-primary endpoint […]Read More
Shots: The approval is based on ENSEMBLE PLUS study, which demonstrated comparable frequency and severity of IRRs for 2hrs. OCREVUS infusion time (dosed twice yearly) vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose single 600mg infusions were administered over a […]Read More
Shots: The US FDA has accepted the sBLA and EMA has validated the application for a 2hrs. Ocrevus (ocrelizumab) infusion time, administered twice yearly for RMS and PPMS The sBLA is based on ENSEMBLE PLUS study, which demonstrated comparable frequency and severity of IRRs for a 2hrs. OCREVUS infusion time vs the currently approved 3.5hrs […]Read More
Shots: The P-III OPERA, ORATORIO and OBOE studies result involves assessing of Ocrevus (ocrelizumab) vs PBO in patients with RMS and PPMS, presented at AAN Annual Meeting Results: reduction in risk of disability progression associated with exposure and lower B-cell levels & permanent disability progression; @24wks. reduction in CDP; @48wks. RMS, PPMS patients with CDP […]Read More
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