FDA Panel Warns Against Approval of Janssen's Sirukumab

The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has recommended against the approval of sirukumab (PLIVENSA), Janssen Biotech’s latest effort to bring a rheumatoid arthritis treatment to the market.

The drug is a fully human monoclonal lgG1 kappa antibody that selectively blocks circulating IL-6, a naturally occurring protein that scientists believe plays a role in autoimmune conditions like rheumatoid arthritis (RA). It is meant for the treatment of active rheumatoid arthritis in adults who’ve had inadequate responses or are intolerant to disease modifying anti-rheumatic drugs (DMARDS), according to Janssen.

The company supported its September, 2016 Biologics License Application (BLA) with efficacy and safety data from a global phase 3 clinical development program that included 5 studies, which tested sirukumab 50 and 100mg doses in more than 3,000 patients living with RA. The drug demonstrated significant efficacy in the treatment of RA, according to a Janssen statement, by inhibiting the progression of structural damage and showing improvement in patient-reported outcome measures like pain, fatigue, physical function and quality of life.

However, in those clinical trials, cardiovascular events, malignancies and mortality were observed. Other serious events included pneumonia and cellulitis, abscess, sepsis, osteomyelitis, hypersensitivity reactions, low platelets, lipid elevations and gastrointestinal perforations.

After reviewing Janssen’s data, the Arthritis Advisory Committee unanimously supported sirukumab’s efficacy data, but not it’s safety profile.

The FDA is not bound by the committee’s decisions, but often followed advisory panels’ decisions in the past. Still, Newman Yeilding, MD, head of immunology development at Janssen Research & Development, LLC, said the company remains confident in the data accumulated in the drug’s phase 3 trials.

“We are disappointed and disagree with the group’s interpretation of the sirukumab benefit-to-risk profile,” Yeilding said. “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.”