FDA approves first immunotherapy combo

as possible MS agents for years. Roche’s first-in-class CD20-binding rituximab yielded promising signs of efficacy in MS, but development in this indication was discontinued for undisclosed reasons. Ocrelizumab, a fully humanized successor to the chimeric rituximab antibody, now picks up the chase. In two Phase III trials in relapsing MS, ocrelizumab beat interferon beta-1a, reducing the annualized relapse rate by nearly 50% compared with the interferon beta-1a comparator. The antibody also outperformed placebo in PPMS. In a 730-patient trial, ocrelizumab reduced the risk of progression of clinical disability sustained for at least 12 weeks by 24% compared with placebo. BioMedTracker analysts forecast global peak sales of ocrelizumab of over US$2 billion in 2024. The antibody was also in development for rheumatoid arthritis, lupus and ulcerative colitis, but has been suspended in all these indications. Asher Mullard Roche hits multiple sclerosis landmarks