Roche has claimed US approval for its much anticipated new multiple sclerosis (MS) drug Ocrevus, and is pricing it at a level that should ensure strong take-up in the market.
The FDA cleared Ocrevus (ocrelizumab) for both relapsing-remitting and primary progressive forms of MS this week after a three-month delay in which the regulator asked for more manufacturing data on the drug.
Ocrevus’ clinical profile has already caught the attention of MS patients and their doctors, with trials showing that the drug outperformed Merck KGaA’s Rebif (interferon beta-1a) in two relapsing MS phase III trials and placebo in a primary progressive MS trial, earning the drug a priority review from the FDA. It is the first drug to be approved for the harder-to-treat primary progressive form of the disease.
At the ECTRIMS conference in London last September, a trial in relapsing MS showed that 72% of Ocrevus-treated patients had no evidence of disease activity between 24 to 96 weeks. A second study in primary progressive MS found a 47% increase in Ocrevus treated patients who showed no evidence of disease progression, indicating their disease had stabilised.
Post-approval, Roche’s pricing of the drug – at around $65,000 per patient per year before discounts – is designed to make sure that Ocrevus makes the maximum impact on the market. It costs 20%-25% less than Rebif and other MS therapies according to analysts, and that should help remove any pushback against adoption by healthcare payers in the US.
All told, there are around 400,000 people with MS in the US, and the Centers for Disease Control and Prevention (CDC) estimates that approximately 15% of those have the primary progressive form.
Analysts at Credit Suisse predicted sales of $1bn for Ocrevus this year rising to almost $4bn in 2020 – driven by rapid uptake in primary progressive MS but also in the relapsing-remitting form, where Ocrevus’ twice-yearly dosing gives it an advantage over other injectable MS therapies such as Biogen’s Tysabri (natalizumab) and Zinbryta (daclizumab).
Ocrevus is designed to selectively target CD20-positive B cells and has been awarded breakthrough therapy status by the FDA for primary progressive MS. The drug is also under regulatory review in Europe with a CHMP verdict due shortly.