FDA News

FDA approves Rituxan for pemphigus vulgaris

Sandra Horning, MD
Sandra Horning

The FDA has approved rituximab for the treatment of adult patients with moderate-to-severe pemphigus vulgaris, a rare autoimmune blistering disease that affects the skin and mucous membranes, according to a company press release.

With this approval, rituximab (Rituxan, Genentech) is the first approved biologic therapy for pemphigus vulgaris, and is now approved to treat four autoimmune diseases, including rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

“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,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “We are pleased to offer Rituxan as a new and effective therapy to patients with this serious condition.”

The FDA based its approval on data from the Ritux 3 trial, a Roche-supported, randomized, controlled trial conducted in France, which compared a European Union-approved rituximab product plus short-term corticosteroid with corticosteroid alone as a first-line treatment in patients with newly diagnosed moderate-to-severe pemphigus.

Primary efficacy endpoints for the Ritux 3 trial were met, with 90% of patients treated with the Ritux 3 regimen achieving complete remission after 24 months without the use of steroids for 2 or more months, compared with 28% of patients who received corticosteroid alone. According to the release, these results support the efficacy of rituximab for the treatment of patients moderate-to-severe pemphigus vulgaris, while tapering off corticosteroid.

In clinical trials, the most common adverse events associated with rituximab in this patient population included infusion reactions and depression. Treatment-related infections also occurred, including herpes simplex, herpes zoster, bronchitis, urinary tract infection, fungal infection and conjunctivitis, according to the prescribing information.

Earlier this year, the International Bullous Disease Consensus Group released new recommendations on the diagnosis and management of pemphigus in the Journal of the American Academy of Dermatology. Based on existing European treatment guidelines, the international panel of experts recommended the use of an anti-CD20 monoclonal antibody — rituximab — plus corticosteroids as first-line therapy options for moderate-to-severe pemphigus.

 Editor's note: This article was updated on June 12 to reflect the correct adverse events experienced among patients with pemphigus vulgaris. We regret the error.

Sandra Horning, MD
Sandra Horning

The FDA has approved rituximab for the treatment of adult patients with moderate-to-severe pemphigus vulgaris, a rare autoimmune blistering disease that affects the skin and mucous membranes, according to a company press release.

With this approval, rituximab (Rituxan, Genentech) is the first approved biologic therapy for pemphigus vulgaris, and is now approved to treat four autoimmune diseases, including rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

“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,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “We are pleased to offer Rituxan as a new and effective therapy to patients with this serious condition.”

The FDA based its approval on data from the Ritux 3 trial, a Roche-supported, randomized, controlled trial conducted in France, which compared a European Union-approved rituximab product plus short-term corticosteroid with corticosteroid alone as a first-line treatment in patients with newly diagnosed moderate-to-severe pemphigus.

Primary efficacy endpoints for the Ritux 3 trial were met, with 90% of patients treated with the Ritux 3 regimen achieving complete remission after 24 months without the use of steroids for 2 or more months, compared with 28% of patients who received corticosteroid alone. According to the release, these results support the efficacy of rituximab for the treatment of patients moderate-to-severe pemphigus vulgaris, while tapering off corticosteroid.

In clinical trials, the most common adverse events associated with rituximab in this patient population included infusion reactions and depression. Treatment-related infections also occurred, including herpes simplex, herpes zoster, bronchitis, urinary tract infection, fungal infection and conjunctivitis, according to the prescribing information.

Earlier this year, the International Bullous Disease Consensus Group released new recommendations on the diagnosis and management of pemphigus in the Journal of the American Academy of Dermatology. Based on existing European treatment guidelines, the international panel of experts recommended the use of an anti-CD20 monoclonal antibody — rituximab — plus corticosteroids as first-line therapy options for moderate-to-severe pemphigus.

 Editor's note: This article was updated on June 12 to reflect the correct adverse events experienced among patients with pemphigus vulgaris. We regret the error.