Trastuzumab/Hyaluronidase

The FDA has signed off on Genentech's subcutaneous version of multiple sclerosis blockbuster Ocrevus, which will give patients a convenient alternative to the treatment's original infused formulation. When Roche's Genentech gained approval for Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Novartis’ next-in-class Kesimpta stole some of Ocrevus’ thunder, offering a convenience edge with its once-monthly, at-home prefilled injection. Now, Genentech has responded with a new formulation as the FDA has endorsed a subcutaneous version of Ocrevus. While it can’t match the at-home convenience of Kesimpta, subcutaneous Ocrevus Zunovo, with its twice-a-year, under-the-skin dosing regimen, provides an attractive option.“This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s medical director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug. For patients who experience side effects, the intravenous infusion can take up to four hours. Oddly enough, on Thursday, Genentech also earned an FDA nod for a subcutaneous formulation of another of its key products as cancer drug Tecentriq Hybreza got a thumbs-up.Setting up Ocrevus Zunovo’s approval was a phase 3 study that showed its noninferiority to its original version as measured by the level of drug in the blood 12 weeks after administration. The injected formulation also matched the performance of the infused treatment in controlling magnetic resonance imaging lesion activity in the brain over 12 weeks.A later look at the OCARINA II study showed that 97% of patients on subcutaneous Ocrevus experienced no relapses for up to 48 weeks after injection. The subcutaneous treatment also suppressed brain lesions by 97%. Most patients had no T1 gadolinium-enhancing lesions or worsening T2 lesions, which are markers of active inflammation and burden of disease. Ocrevus Zunovo requires more medicine, at 920 mg per dosing, versus 600 mg for an infusion, which is “not really surprising because not all of the drug is going to be absorbed,” Jones said. Ocrevus is designed to target CD20-positive B cells, which are responsible for inflammatory damage to nerve cells in MS.Ocrevus Zunovo was developed using Halozyme Therapeutics’ Enhanze drug delivery technology, which employs an enzyme to allow large molecules like Ocrevus to be given under the skin.The hookup between the companies is well established as it paved the way for the Tecentriq Hybreza FDA nod as well as approvals for subcutaneous versions of Genentech’s blood cancer drug Rituxan Hycela and injectable cancer treatments Herceptin Hylecta and Phesgo. Ocrevus is currently Roche’s top-selling product, with 2023 sales reaching 6.38 billion Swiss francs ($7 billion), which was good for 13% growth over 2022 at constant exchange rates. Ocrevus holds about a 24% MS patient share across the U.S. and five largest European markets.Meanwhile, Kesimpta doubled sales in 2023 to $2.17 billion. The drug has secured new-to-brand share leadership in seven of the 10 major markets outside of the U.S., according to a Novartis report in January.The two CD20 antibodies are among the most expensive MS treatments. While Ocrevus carries a list price of $79,000 annually, Kesimpta goes for $83,000 per year before rebates and discounts.Another force in the MS market is Merck KGaA’s DMD treatment Mavenclad, which generated sales of $1.1 billion last year. Former MS blockbusters that have lost their market exclusivity in the last few years include Teva’s Copaxone, Sanofi’s Aubagio and Novartis’ Gilenya.