PV is a rare autoimmune disease that causes blistering on the skin and mucous membranes. It is the most common form of a group of autoimmune disorders called pemphigus, each of which are characterized by skin blisters. Most common areas affected for PV are the mouth, throat, nose, eyes, genitals and lungs. It can be dangerous. Prior to this approval, the most common form of treatment was corticosteroids to suppress the immune system. It can sometimes be fatal.
The FDA approval makes Rituxan the first biologic approved for PV and the first major improvement in treatment for it in more than 60 years.
“I’m excited by the approval of Rituxan as an effective, much-needed, FDA-approved treatment option for patients who are currently faced with a treatment regimen that can cause significant, long-term side effects,” said Victoria Werth, professor of Dermatology and Medicine at the University of Pennsylvania, in a statement.
The approval was based on data from the Ritux 3 clinical trial, a randomized, controlled trial conducted in France using Roche’s rituximab, which had been approved for use in the European Union. The trial compared patients on rituximab and corticosteroids to those receiving corticosteroids alone. The study indicated that 90 percent of PV patients receiving the Ritux 3 regiment met the primary endpoint, compared to only 28 percent treated with corticosteroids alone.
The primary endpoint was complete remission at month 24 without the use of steroids for two or more months. This underlines the treatment procedures, which are Rituxan plus steroids, tapering off the steroids. The results of the trial were published in the March 2017 issue of The Lancet.
This expands the drug’s approval to four autoimmune diseases, including PV, rheumatoid arthritis, granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis.
Rituxan is also marketed under the trade name MabThera. In the first quarter of 2018, it brought in $1.73 billion in sales, a decrease of 8 percent because of biosimilar competition in Europe. JP Morgan analysts have projected revenues for the drug will continue to fall by 16 percent this year.
The Pharma Letter writes, “The International Bullous Disease Consensus Group recently provided new recommendations relating to diagnosis and management of the disease. Taking into consideration European treatment guidelines, the panel of experts used a Delphi survey process to achieve international expert consensus. The consensus includes the recommendation to use rituximab along with corticosteroids as first-line therapy for patients with moderate to severe pemphigus.”
Those recommendations were published in the Journal of the American Academy of Dermatology.
“Today’s decision by the FDA provides the first approved treatment opinion in more than 60 years for patients with pemphigus vulgaris, a potentially life-threatening disease,” said Sandra Horning, Roche and Genentech’s chief medical officer and head of Global Product Development, in a statement. “We are pleased to offer Rituxan as a new and effective therapy to patients with this serious condition.”
A Product Manager with expertise in pharma marketing and sales operations