Patients suffering from moderate to severe rheumatoid arthritis and who have not responded to one or more TNF inhibitors (like Cimzia, Enbrel, Humira, Remicade, and Simponi) can avail of Actemra, an FDA approved drug. This is the first IL-6 inhibitor for arthritis and it is given by once-monthly hour-long infusions.
The drug cannot be used in combination with TNF inhibitors or other biologic treatments for arthritis. Actemra can be used with disease-modifying drugs like methotrexate.
The drug is approved for relatively severe disease, but Roche is working with FDA to extend approval to patients who have an early stage of rheumatoid arthritis (RA).
Roche Chief Medical Officer Hal Barron, MD said in a news release that they believe that their work with FDA will generate additional data that is required to support approval of treating patients with early stages of rheumatoid arthritis.
Arthritis patients have increased IL-6 (or interleukin -6) levels which is a chemical messenger that is involved in the destructive immune responses. In 2008, an FDA advisory panel voted ten to one in favor of approving Actemra which is also known by generic name tocilizumab. The drug is already approved in Europe, Japan and Australia.
The drug was created by Genentech which is now a part of drug giant Roche. An extensive clinical research showed that the drug effectively reduces arthritis symptoms in patients who do not respond to TNF inhibitors. Side effects that were discovered during these trials include serious infections, sever allergic reactions and diverticulitis. Also, some patients showed increased levels of cholesterol and blood fats.
It was agreed with a company that an extensive post-marketing safety study will be carried out. The company will also support an active program to monitor patients who are taking the drug.
Roche says that the drug will be available to U.S. patients the week of January 18.