FDA delays decision on key Roche MS drug

Roche will likely have to wait until late March for US regulators to make a decision on its multiple sclerosis drug, Ocrevus.

The regulator was to rule on Ocrevus (ocrelizumab) in a week’s time, after having awarded it a faster six-month review following a filing at the end of June.

But the FDA has extended this decision date to 28 March, after Roche submitted additional data regarding the commercial manufacturing process of Ocrevus.

This will take extra time for the FDA for review, although Roche noted in a statement that the extension is not related to the efficacy or safety of Ocrevus.

Ocrevus is likely to be a key drug for Roche, with EP Vantage predicting sales of around $4.4 billion by 2020.

Late stage trial data published in September showed Ocrevus is better at controlling disease in relapsing MS than Merck KGaA’s Rebif (interferon beta-1a).

Ocrevus was also able to halt disease progression in almost half (47%) of patients with primary progressive MS, a form of disease for which there is no approved treatment.

Although it will compete with Biogen’s Tecfidera (dimethyl fumarate), Roche will have to give back some of its profits to its rival.

Biogen will get a royalty from Ocrevus, as part of a 2010 agreement stemming from a development partnership involving the drug.

Roche’s chief medical officer and global head of product development, Sandra Horning, said: “We strongly believe in the potential of Ocrevus as a new therapeutic option for both people with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).”

“We are working closely with the FDA during their review and committed to bringing this innovative medicine to the over 400,000 people with MS in the US living with this disabling disease as quickly as possible.”

Ocrevus is a humanised monoclonal antibody designed to selectively target CD20-positive B cells. These are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS.

Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

The European Medicines Agency is also reviewing Ocrevus.