The Swiss company announced that both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted its supplemental biologics license application (sBLA) to reduce the infusion time of Ocrevus (ocrelizumab).
Ocrevus is approved to treat patients with relapsing or primary progressive multiple sclerosis.
Currently, patients are administered two 300mg infusions, separated by two weeks, before subsequent doses of 600mg are delivered every six months – with the latter infusions taking three and a half hours. The sBLA aims to reduce the time needed for infusion down to two hours.
The application is based on data from a trial measuring the frequency and severity of infusion-related reactions (IRRs) related to the reduction of infusion time.
According to Roche, the trial comparing those administered the follow-up doses over two hours showed comparable IRRs and no patients discontinued the trial due to IRRs.
The FDA and EMA are expected to make a decision on the sBLAs by the end of 2020.
Ocrevus has been a major growth driver for Roche since its approval in 2017 and the product achieved sales of CHF 3.7bn (€3.5bn) in full-year 2019 results, representing 57% year-on-year growth.
The company’s efforts at increasing the convenience of Ocrevus comes as rival oral-dose treatments, such as Merck KGaA’s Mavenclad (cladribine), now exist on the market and offer the ability to maintain treatment through the taking of a pill.