Although, the FDA is not obliged to go by the recommendation of the committee, more often or not it takes its advice into consideration.
The drug, which is proposed to have a trade name Plivensia, has been seeking approval for the treatment of moderately to severely active form of RA in adults who either had insufficient response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
An anti-interleukin (IL)-6 monoclonal antibody, sirukumab blocks the IL-6 pathway through a different approach when compared to the current approved IL-6 inhibitors for RA treatment.
The Arthritis Advisory Committee had unanimously voted in support of sirukumab’s efficacy. However, its members were not sure about its safety profile which led to them in not recommending approval for the proposed indication.
Janssen research & development immunology development head Newman Yeilding said: “We are disappointed and disagree with the group’s interpretation of the sirukumab benefit-to-risk profile.
“We remain confident in the data accumulated to date supporting sirukumab in the treatment of moderately to severely active rheumatoid arthritis. We look to continue discussions with the FDA in their review of the application as we believe sirukumab represents an important therapeutic option for patients with rheumatoid arthritis.”
The review by the committee was based on the efficacy and safety data gathered from a phase 3 trial comprising five studies. They were held in over 3,000 RA patients including those who still have active disease in spite of receiving DMARD and biologic treatments in the past.
According to Janssen, the trial showed Sirukumab administered at 50mg and 100mg every four and two weeks respectively had shown significant efficacy in treating the disease. Besides, the drug was shown to improve signs and symptoms of RA while blocking the progression of structural damage.