Recently, Genetech, a subsidiary of Roche (RHHBY.US), announced that its major antibody therapy ORevus has obtained positive data in the phase 3 clinical study Ocarina II to treat recurrent or primary progressive multiple sclerosis.
The Zhitong Finance App learned that recently, Genentech (Genentech), a subsidiary of Roche (RHHBY.US), announced that its major antibody therapy Ocrevus has obtained positive data in the phase 3 clinical study Ocarina II to treat recurrent or primary progressive multiple sclerosis (RMS or PPMS). The results showed that the Ocrevus subcutaneous preparation, which only took two doses a year, almost completely inhibited clinical recurrence and brain lesions.
Updated long-term follow-up results showed that Ocrevus subcutaneous injection (920 mg; n=236) almost completely inhibited recurrent activity during the treatment phase (97.2% of patients did not relapse during treatment). The annual recurrence rate during the 48-week nuclear magnetic resonance imaging (MRI) test was 0.04, and the vast majority of patients had no Gd+ T1 lesions and no new/expanded T2 lesions. These lesion types are signs of active inflammation and disease burden, respectively. Furthermore, in an exploratory patient-reported outcome index, patients (n=52) reported high levels of satisfaction (92.3% of patients were satisfied or very satisfied) and convenience (90.1% of patients found it convenient or very convenient).
According to reports, the European Medicines Agency (EMA) and the US FDA have accepted the regulatory application submitted by Genentech. The EMA's target decision date is mid-2024, and the FDA's target decision date 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 300,000 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.