On 13 July 2023, Genentech announced positive results from its Phase III trial, OCARINA II (NCT05232825), investigating the efficacy of subcutaneous ocrelizumab, in patients diagnosed with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). In its intravenous (IV) formulation, ocrelizumab is known as Ocrevus and has been approved for use in multiple sclerosis (MS) since 2017.
In its press release, Roche announced that the trial met all of its primary and secondary endpoints and that detailed results from the trial will be presented at an upcoming medical meeting.
Ocrevus quickly established itself on the market after approval, not only due to its favourable efficacy and positive safety profile but also because it was the first agent officially approved for use in PPMS patients, which is a more difficult population to successfully treat in comparison to RMS. However, the IV administration of Ocrevus can be time-consuming and uncomfortable for patients, as they need to receive the medication twice yearly over the course of a two-hour infusion, therefore a subcutaneous ocrelizumab could bring new opportunities to MS patients. Subcutaneous ocrelizumab is administered twice yearly for only ten minutes.
According to GlobalData’s recent report, Multiple Sclerosis: Seven-Market Drug Forecast and Market Analysis to 2030 – Update, Ocrevus is expected to dominate the MS market in 2030, generating $6.3B across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). However, these sales are expected to have fallen from their peak in 2027 ($7.3bn) due in great part to patients switching to newer agents with more convenient methods of administration, such as Novartis’s Kesimpta, which is administered in the form of subcutaneous injection every four weeks. Kesimpta is expected to generate sales of $4.5bn in 2030 across the 7MM.
In recent years, approval of new agents with positive clinical profiles and more convenient routes of administration for MS such as Kesimpta have begun to drive drug-switching among treatment-experienced patients as well as attract new patients just starting their treatment. However, if the subcutaneous formulation of ocrelizumab gains FDA approval, the agent might have an easier time retaining its customer base and even start attracting new patients who are searching for a reliable and safe agent with a convenient administration route. Nonetheless, there is still a wait for Roche to release the full data from the clinical trial before a full picture of the impact this product would have on the MS market starts to emerge, especially as new oral pipeline products such as tolebrutinib and evobrutinib are expected to enter the already overcrowded MS market in 2025, making the space even more competitive.