Following the news that the US Food and Drug Administration (FDA) has 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);

Sarah Elsayed, MBA, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“Ocrevus boasts a superior pharmacological profile in the MS market due to its high efficacy, good tolerability and convenient six-month dosing regimen via intravenous infusion (IV). 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 to $7.6bn by 2028, according to GlobalData’s latest forecast.

“The MS market is considered to be among 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 2020, for patients with different forms of RMS.

“Both drugs are anti-CD20 monoclonal antibodies (mAb), with a rather comparable mechanism of action of destroying B-cells associated with inflammation in MS. However, the two drugs have distinct routes of administration, Kesimpta is a monthly subcutaneous (SC) treatment that patients can self-administer at home, as opposed to Ocrevus’ IV infusion that is delivered at hospital twice a year. Another key differentiator is that Ocrevus is the only drug FDA-approved for the rarer 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. Finally, Kesimpta has the potential to steal some market share from new and switching patients due to its way of administration, however, given the first-to–market advantage that Ocrevus possess and the absence of a head-to-head clinical study, Ocrevus is likely to retain its leadership position through 2028 and outperform Kesimpta, which is forecasted to generate $3.3bn by 2028.”