Roche has been granted marketing authorization by Switzerland’s medicines regulator, Swissmedic, for Ocrevus (ocrelizumab) for both relapsing and primary progressive forms of multiple sclerosis.
The drug, which is expected to add billions to the firm’s annual income, was approved in these indications in the USA in March. The European Medicines Agency is still reviewing Roche’s regulatory filing.
Roche is supporting its regulatory filings with data from the Phase III ORATORIO and OPERA studies.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze