We have an update for you regarding Ocrelizumab – the investigational disease modifying therapy that we have told you about over the past several months.
Last week, the FDA officially notified Genentech that they are extending their review of the Ocrevus (ocrelizumab) application. The extension is not related to the efficacy or safety of Ocrevus. Rather, the FDA requires more time to review additional data and information regarding the manufacturing process.
The announcement has no impact on patients involved in any of the ocrelizumab clinical trials. In addition, the expanded access program for eligible PPMS patients continues unchanged.
We will keep you posted on the timing going forward.