Genentech receives FDA review acceptance for Ocrevus’ biologics licence application

28 June 2016 (Last Updated June 28th, 2016 18:30)

Swiss-based company Roche's subsidiary Genentech has received acceptance for review from the US Food and Drug Administration (FDA) for its biologics licence application (BLA) for Ocrevus (ocrelizumab) to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

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Swiss-based company Roche's subsidiary Genentech has received acceptance for review from the US Food and Drug Administration (FDA) for its biologics licence application (BLA) for Ocrevus (ocrelizumab) to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

Ocrevus is an investigational, humanised, monoclonal antibody used to selectively target CD20-positive B cells, a specific type of immune cell that contributes to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.

The FDA has also granted the application Priority Review Designation for Ocrevus with a targeted action date of 28 December this year.

The marketing authorisation application (MAA) for Ocrevus (ocrelizumab) has also been validated by the European Medicines Agency (EMA).

Genentech global product development chief medical officer and head Dr Sandra Horning said: "Ocrevus is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS.

"We will continue to work closely with the FDA and EMA to bring this investigational medicine to people with MS as quickly as possible."

"We are pleased by the FDA's decision to classify their review of the BLA as priority because we believe Ocrevus has the potential to help people living with either of these two forms of MS.

"We will continue to work closely with the FDA and EMA to bring this investigational medicine to people with MS as quickly as possible."

Once approved by the FDA and EMA for both indications, ocrelizumab will become the first and only treatment that can be used on both forms of MS, which affect nearly 95% of people at diagnosis.

MS is a chronic disease that occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, optic nerves and spinal cord, thereby causing inflammation and consequent damage.


Image: Photomicrograph of a demyelinating multiple sclerosis-lesion. Photo: courtesy of Marvin 101.