Shorter Ocrevus Infusion Time Up for Approval in US and Europe

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted applications from Genentech to shorten the infusion time for Ocrevus, an approved treatment for multiple sclerosis.

If approved, the time to administer Ocrevus will be shortened to a two-hour session, instead of the currently approved 3.5 hours, twice per year.

Ocrevus (ocrelizumab) works by targeting B-cells, a type of immune cell that drives the inflammation that damages the nervous system in MS. The therapy was developed by Genentech, a member of the Roche Group.

In both the U.S. and Europe, Ocrevus is approved for the treatment of relapsing forms of MS (including relapsing-remitting MS and active secondary progressive MS). It also is approved for primary progressive MS —  the first medication ever approved for that type of MS.

Ocrevus is administered by infusion, which is when a therapy is slowly dripped into the bloodstream over a period of time. The approved dosing schedule is to first receive two 300 mg infusions two weeks apart, then to receive 600 mg infusions every six months.

“With more than 150,000 people treated with Ocrevus, the twice-yearly dosing schedule has benefited many MS patients and their physicians, as indicated by more than 90 percent of patients continuing with treatment through one year [according to data from the U.S. PharMetrics Plus commercial claims database],” Levi Garraway, MD, PhD, said in a press release. Garraway is chief medical officer and head of Global Product Development at Roche.

“We hope a shorter infusion time will further improve the experience for people living with MS, while also increasing capacity in healthcare systems,” Garraway said.

The applications to shorten the approved infusion time to 2 hours are based on data from the clinical trial ENSEMBLE PLUS.

“The currently approved infusion time for ocrelizumab is approximately 5.5-6h [hours], which includes premedication and infusion set-up (1h), ocrelizumab infusion (3.5-4h), and post-infusion observation (1h). A reduction in infusion time may reduce the burden of administration on the patient, nursing staff and hospital facilities,” the researchers wrote in a published article about ENSEMBLE PLUS’s study design.

In this trial (NCT03085810), participants received the first two 300 mg infusions over the normal 3.5 hours. Then, for the subsequent 600 mg infusions, participants were divided into two groups: one group continued to receive the infusions over 3.5 hours, while the other received two-hour  infusions.

The study compared the frequency and severity of infusion-related reactions (IRR) — adverse side effects that occur during or within a day of the infusion. IRRs are the most common side effect associated with Ocrevus treatment.

Data showed comparable frequency and severity of IRRs for the two regimens  (two-hour infusion and standard Ocrevus infusion time). No participants discontinued the study due to IRRs, and no new safety concerns were reported.

Genentech announced that detailed results from the trial will be reported “at the earliest opportunity.”

The FDA and EMA are expected to make decisions regarding the applications before the end of this year.