Roche Ocrevus New Infusion Solution Approved By The EU

- Jun 09, 2020-

On May 28, Roche announced that the European Medicines Agency (EMA) has approved Ocrevus (ocrelizumab) a new, shorter time-consuming 2-hour infusion regimen, administered twice a year for relapsed or primary progressive Treatment of multiple sclerosis (MS). This approval is based on the positive review opinion of the EMA Committee for Human Medical Products (CHMP).


The approval was based on data from a randomized, double-blind ENSEMBLE PLUS study. The study showed that in patients with relapsing-remitting multiple sclerosis (RRMS) (289 patients received a 2-hour infusion and 291 patients received a conventional 3.5-hour infusion), 2-hour infusion and 3.5-hour infusion related to infusion (IRR) frequency and severity are comparable. In the study, the first dose was in accordance with the approved dosing schedule (two 300 mg IV [IV] infusions, separated by 2 weeks), and the second or subsequent dose (600 mg IV infusion) was administered for a shortened 2-hour schedule .


The primary endpoint of the study was the proportion of patients with IRR after the first random infusion (frequency and severity of assessment during infusion and 24 hours after infusion). The results showed that the incidence of IRR was comparable between the 2-hour infusion group (24.6%) and the 3.5-hour infusion group (23.1%). The two groups of IRR were mainly mild or moderate, and more than 98% were resolved without complications. No life-threatening, serious and fatal IRR occurred. No patient discontinued the study due to IRR and no new safety signal was detected.


The US FDA has also accepted the Ocrevus 2 hour infusion solution supplementary biological product license application (sBLA), is expected to make a decision on December 14 this year.


Ocrevus is a humanized monoclonal antibody directed against CD20-positive B cells, which are a specific type of immune cell and are thought to be damaged by myelin sheath (neural cell isolation and support) and axons (nerve cells) The key factor. This nerve cell damage can cause disability in MS patients. According to preclinical studies, Ocrevus binds to certain CD20 cell surface proteins expressed by B cells, but not to stem cells or plasma cells, indicating that important functions of the immune system can be preserved.


Ocrevus was approved for marketing in March 2017. Due to the therapeutic advantages of only twice a year, once it is marketed, it is quickly accepted by patients. Currently, Ocrevus has been approved in 90 countries around the world. Ocrevus’ real-world experience is rapidly increasing, with more than 160,000 patients receiving treatment worldwide. The drug is administered twice a year and is the first and only approved for the treatment of RMS (including RRMS, active or recurrent secondary progressive MS, and clinically isolated syndrome in the United States) and primary progressive MS method.


According to the performance report released by Roche, Ocrevus' global sales in 2019 reached CHF 3.708 billion, an increase of 57% over the previous year. In the first quarter of this year, Ocrevus' sales reached 1.112 billion Swiss francs, an increase of 38% over the same period of the previous year.