pennpursuit3reel| Roche's (RHHBY.US) heavy-weight antibody therapy Ocrevus Phase 3 clinical data obtains positive data

Business editor 2024-04-26 12:25 10 0

Zhitong Financial APP learned thatPennpursuit3reelRecently, RHHBYPennpursuit3reel(us) Genentech (Genentech) announced that its blockbuster antibody therapy Ocrevus is in the treatment of recurrent or primary progressive multiple sclerosis (RMS or PPMS)Pennpursuit3reelPositive data were obtained from the phase 3 clinical study OCARINA II. The results showed that subcutaneous injection of Ocrevus only twice a year almost completely inhibited clinical recurrence and brain lesions.

pennpursuit3reel| Roche's (RHHBY.US) heavy-weight antibody therapy Ocrevus Phase 3 clinical data obtains positive data

Updated long-term follow-up results showed that subcutaneous injection of Ocrevus (920mg; nude 236) almost completely inhibited recurrence activity during the treatment phase (97.Pennpursuit3reel.2% of the patients did not relapse during the treatment period. The annual recurrence rate was 0.04 in 48-week magnetic resonance imaging (MRI). Most patients had no Gd+T1 lesions and no new / enlarged T2 lesions. These types of lesions are signs of active inflammation and disease burden, respectively. In addition, among the exploratory patient reporting outcome indicators, patients (nasty 52) reported high levels of satisfaction (92.3% of patients were satisfied or very satisfied) and convenience (90.1% of patients considered it convenient or very convenient).

It is reported that the European Drug Administration (EMA) and the US FDA have accepted the regulatory application submitted by Genentech. The target decision date for EMA is 2024, and the target decision date for FDA is September 2024. The regulatory application for Ocrevus subcutaneous preparations is currently being reviewed by European and US regulators and is expected to be approved this year. More than 300000 patients worldwide have been treated with intravenous Ocrevus. This dosage form has been approved in more than 100 countries and regions, including North America, South America, the Middle East, Eastern Europe, Asia, Australia, Switzerland, the United Kingdom and the European Union.