Regulatory Affairs

Genentech’s Rituxan gets FDA approval to treat pemphigus vulgaris

PBR Staff Writer Published 08 June 2018

Genentech, a subsidiary of Roche, has secured approval from the US Food and Drug Administration (FDA) for its antibody therapy Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris (PV).

Considered to be potentially life-threatening, pemphigus vulgaris is an autoimmune blistering disease that affects the skin and mucous membranes. Patients with this condition suffer from progressive painful blistering of the skin and mucous membranes.

The FDA approval was driven by the results of the Ritux 3 trial, which evaluated a rituximab-based regimen to corticosteroids (CS) alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus.

The rituximab-based regimen comprised rituximab product, which was approved in the European Union, and short-term CS.

Results of the trial showed that the 90% of the patients on Ritux 3 regimen met the primary endpoint of complete remission at month 24 without the use of steroids for two or more months. This was in comparison to 28% of PV patients who were subjected to only CS.

The latest approval in the US makes Rituxan the first biologic therapy endorsed by the FDA for PV. It also marks the first important advancement in the treatment of the condition in more than six decades.

Prior to the approval, Rituxan was granted the priority review, breakthrough therapy designation and orphan drug designation by the FDA for the treatment of PV.

Genentech chief medical officer and global product development head Sandra Horning said: “Today’s decision by the FDA provides the first approved treatment option in more than 60 years for patients with pemphigus vulgaris, a potentially life-threatening disease.

“We are pleased to offer Rituxan as a new and effective therapy to patients with this serious condition.”

Following the latest FDA decision, Rituxan is now indicated for the treatment of four autoimmune diseases that include rheumatoid arthritis, Granulomatosis with Polyangiitis and microscopic polyangiitis to go along with pemphigus vulgaris.

Earlier, this week, Genentech secured FDA priority review for its bispecific factor IXa- and factor X-directed antibody Hemlibra (emicizumab) to treat haemophilia A without factor VIII inhibitors in adults and children.

Image: Genentech’s location in South San Francisco, US. Photo: courtesy of F. Hoffmann-La Roche Ltd.