Roche Secures Another Subcutaneous FDA Approval for MS Drug Ocrevus

The FDA has recently approved Genentech's subcutaneous version of the multiple sclerosis drug Ocrevus, providing patients with a new, convenient alternative to the original infused formulation. Ocrevus, first approved in 2017, quickly became a leading treatment in the competitive multiple sclerosis (MS) market. However, its dominance was challenged by Novartis’ Kesimpta in 2020, which offered the convenience of a once-monthly, at-home prefilled injection. In response, Genentech has developed Ocrevus Zunovo, a subcutaneous version of Ocrevus, which the FDA has now endorsed.

Although Ocrevus Zunovo does not offer the same at-home convenience as Kesimpta, it presents a viable option with its twice-a-year, under-the-skin dosing schedule. According to David Jones, Genentech’s medical director for MS, this new formulation can be administered in clinics, eliminating the need for patients to visit infusion centers. This is particularly beneficial for individuals in remote areas or those with limited access to healthcare providers.

The subcutaneous version of Ocrevus can be injected in just 10 minutes, a significant reduction from the two or more hours required for the intravenous infusion. For patients experiencing side effects, the infusion process can take up to four hours. On the same day as the Ocrevus Zunovo approval, the FDA also greenlit a subcutaneous formulation of another Genentech product, the cancer drug Tecentriq Hybreza.

The approval of Ocrevus Zunovo was based on a phase 3 study demonstrating its noninferiority to the original intravenous version, as measured by the level of drug in the blood 12 weeks post-administration. The subcutaneous formulation also matched the infused treatment in controlling MRI-visible lesions in the brain over the same period.

Further analysis from the OCARINA II study revealed that 97% of patients on subcutaneous Ocrevus experienced no relapses for up to 48 weeks after the injection. Additionally, the treatment suppressed brain lesions by 97%, with most patients showing no new or worsening T1 gadolinium-enhancing lesions or T2 lesions, which are indicators of inflammation and disease burden.

Ocrevus Zunovo requires a higher dose of medication—920 mg per dose compared to 600 mg for the infusion. This is because not all of the drug is absorbed when administered subcutaneously. Ocrevus targets CD20-positive B cells, which contribute to the inflammatory damage seen in MS.

The development of Ocrevus Zunovo involved Halozyme Therapeutics’ Enhanze drug delivery technology. This technology uses an enzyme to facilitate the subcutaneous administration of large molecules like Ocrevus. This collaboration also led to the FDA approval of Tecentriq Hybreza and subcutaneous versions of Genentech’s other drugs, such as Rituxan Hycela, Herceptin Hylecta, and Phesgo.

Ocrevus remains Roche’s top-selling product, with 2023 sales reaching 6.38 billion Swiss francs ($7 billion), reflecting a 13% growth over 2022. The drug holds about a 24% share of the MS market in the U.S. and the five largest European countries. Meanwhile, Kesimpta saw its sales double in 2023 to $2.17 billion and has secured new-to-brand share leadership in seven of the 10 major markets outside the U.S.

Both Ocrevus and Kesimpta are among the most expensive MS treatments, with annual list prices of $79,000 and $83,000, respectively, before rebates and discounts. Other notable players in the MS market include Merck KGaA’s Mavenclad, which generated $1.1 billion in sales last year, and former blockbusters like Teva’s Copaxone, Sanofi’s Aubagio, and Novartis’ Gilenya, which have lost market exclusivity in recent years.