Trial results from Roche’s blockbuster, Ocrevus (ocrelizumab), were presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on 13 September in Sweden.
Longer-term data from the Phase III, open-label extension studies — OPERA I, OPERA II, and ORATORIO — showed a 42 % reduction in the risk of primary progressive multiple sclerosis (PPMS) patients needing a wheelchair after 6.5 years of Ocrevus treatment compared with patients who started Ocrevus after the double-blind period. This effect was sustained over time. Importantly, Ocrevus safety remains in line with the benefit-risk profile assessed in pivotal studies and assigned in the label.
MS market leader
Ocrevus has become the MS market leader in its class since its approval in 2017. Key opinion leaders have endorsed it as the best monoclonal antibody on the market due to its superior efficacy and its six-month dosing regimen via intravenous infusion. The drug has steadily gained market share, and it was prescribed to almost 40% of patients starting MS treatment as of Q2 2019, according to Roche. Regarded as the most successful launch in Roche’s history, Ocrevus global sales totalled $1.72bn over H1 2019 and are expected to reach $6.8bn by 2025, according to GlobalData.
These unique findings indicate that Ocrevus is set to maintain its leadership, although Roche still needs to monitor new competitive threats coming from its strong MS rivals such as Novartis and Sanofi. Novartis’ Arzerra (ofatumumab), a little-used cancer drug, could pose a challenge to Roche following recent study results showing that the drug convincingly reduced relapses and slowed disability progression in MS patients comparably with Ocrevus’ performance in the trials that led to its approval. Both Arzerra and Ocrevus are anti-CD20 drugs.
MS late-stage pipeline
The MS market has witnessed remarkable growth with a wide range of treatment options and many promising late-stage pipeline drugs. The future of the MS treatment market looks bright, with a number of planned regulatory filings intended by the end of 2019, including Novartis’s Arzerra and Johnson & Johnson’s oral drug ponesimod, which outperformed Sanofi’s blockbuster Aubagio (teriflunomide) in a Phase III comparative trial. Thus, GlobalData forecasts market approvals for Arzerra by Q3 2021 and ponesimod by Q4 2020.
In addition to Ocrevus’ strong efficacy and consistent overall safety data, separate analysis from the same study presented at ECTRIMS showed greater patient satisfaction after one year on treatment. Furthermore, Ocrevus now boasts rapidly increasing real-world experience with more than 120,000 MS patients treated globally, which is another advantage for the product.
GlobalData (2019). Multiple Sclerosis: Global Drug Forecast and Market Analysis to 2029, to be published.