The FDA has approved Roche’s Ocrevus, a drug for multiple sclerosis that so far has proved to work better than any other medicines in the market. 

Ocrevus (ocreluzimab) has been cleared to hit the shelves by the FDA, and Roche expects the drug to bring a massive €3.8Bn a year in revenues by 2022. Its approval is based on outstanding results from a Phase III trial completed last September that showed Ocrevus performed better than Merck’s Rebif, currently the leading MS drug, over a two-year period.

Aside from better results than previous treatments in relapsing-remitting MS (RRMS), the most common form of the disease, Ocrevus will bring new hope for patients suffering from the most aggressive form of multiple sclerosis, primary progressive MS (PPMS). No treatment was available until now for this form of the disease, which afflicts up to 15% of MS patients.

Multiple sclerosis is caused by the progressive elimination of myeloid cells that protect neurons, a process often mediated by attacks from immune cells

The key to Ocrevus’ success in the clinic is a unique mechanism of action. The antibody drug binds the CD20 antigen of B cells instead of targeting T cells like all other approved MS drugs do. The new drug is delivered via injection twice a year, with a projected annual price tag of €60,000 ($65,000) in the US, which is 25% lower than its rival Rebif.

In Europe, the EMA is still reviewing Roche’s application for marketing authorization. Although prices tend to be lower in Europe thanks to negotiations with national regulatory agencies, the lack of competition in a market expected to reach a huge €23Bn by 2024 is expected to ensure high revenues for Roche.

The FDA’s approval of Ocrevus is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B-cell targeted therapy”, said Sandra Horning, CMO at Roche.

Although Roche will enjoy a few years of exclusivity, the future will keep bringing more and better solutions for MS patients. Biotech has several innovative treatments for MS in the pipeline, such as TxCell’s CAR-Treg, Apitope’s MS vaccine, Ossianix’ shark-inspired antibodies or Geneuro’s unique antibody technology.


Images via Orawan Pattarawimonchai /Shutterstock; AP Ross et al. (21013), Front. Neurol. 4:21

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