On 14 December, the US Food and Drug Administration (FDA) approved a shorter two-hour infusion time for Roche ’s Ocrevus (ocrelizumab) in patients with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). This approval was based on data from the randomised, double-blind ENSEMBLE PLUS study, which showed consistent safety of the new shorter infusion compared to the conventional 3.5-hour infusion dosing regimen. The primary endpoint of this study was to identify the percentage of patients with infusion reactions (IRs), following the first infusion. IR frequency was comparable between those who received the two-hour infusion (24.6%) and those who received the 3.5-hour infusion (23.1%). The IRs were only mild without any serious complications.
Ocrevus boasts a superior pharmacological profile in multiple sclerosis (MS) market due to its high efficacy, good tolerability, and convenient six-month dosing regimen via intravenous (IV) infusion. The new FDA approval will further improve patients’ satisfaction as it cuts the overall treatment duration to less than four hours compared to the former average of six hours, including the duration of the premedication administration and post-infusion monitoring. This dosing advantage will bolster Ocrevus’ market leadership and drive its global sales growth, reaching $7.6bn by 2028, according to GlobalData’s forecast.
The MS market is considered to be the most lucrative in the neurology space due to the wide range of current treatment options and promising late-stage pipeline drugs. As such, Ocrevus is expected to face tough competition in the near future. The strongest direct rival to watch for is Novartis’ Kesimpta (ofatumumab), which was FDA-approved in August for patients with different forms of RMS.
Ocrevus is a humanised monoclonal antibody (mAb) that works by selectively depleting CD20-positive B cells, a specific type of immune cell thought to be involved in the attack on myelin in MS patients. Both drugs are anti-CD20 mAbs with a rather comparable mechanism of action, but they have distinct routes of administration. Kesimpta is a monthly subcutaneous (SC) treatment that patients can self-administer at home while Ocrevus’ IV infusion is delivered at the hospital twice a year. Additionally, Ocrevus is the only drug FDA-approved for the more rare and severe PPMS. Furthermore, the annual cost of treatment for Kesimpta ($83,000) is slightly higher than that of Ocrevus ($65,000), excluding any extra mobility costs.
Kesimpta has the potential to steal some market share from new and switching patients due to its route of administration. However, given Ocrevus’ first-to-market advantage and the absence of a head-to-head clinical study, Ocrevus is likely to retain its leadership position through 2028 and outperform Kesimpta, which GlobalData forecasts to generate $3.3bn by 2028.