Janssen’s Plivensia given thumbs down by US advisors

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US regulatory advisors are not recommending approval of Johnson & Johnson’s Plivensia for rheumatoid arthritis, having concluded – based on the data available – that the benefits of the drug do not outweigh the potential risks.

The Arthritis Advisory Committee of the US Food and Drug Administration voted 12 to 1 against approving the drug to treat moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).

The Committee looked at efficacy and safety data from a global Phase III clinical development programme inclusive of five studies and more than 3,000 patients living with RA, including those who continue to have active disease despite previous DMARD and biologic treatments.

While there was unanimous support for efficacy, the Committee was not convinced of Plivensia’s (sirukumab) safety profile, primarily because of a higher number deaths in the treatment group versus placebo, largely due to cardiovascular problems, malignancies and infection.

“We are disappointed and disagree with the group’s interpretation of the sirukumab benefit-to-risk profile,” said Newman Yeilding, head of Immunology Development, Janssen Research & Development.

“We remain confident in the data accumulated to date supporting sirukumab in the treatment of moderately to severely active rheumatoid arthritis [and] 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.”

Plivensia is an experimental anti-interleukin (IL)-6 monoclonal antibody that blocks the IL-6 pathway differently than others already on the market for the treatment of RA.

Janssen and GSK formed a co-development and co-commercialisation pact for sirukumab in RA back in 2011. The agreement allows both companies the option to investigate the drug for other indications beyond RA; GSK is also testing sirukumab in a Phase III trial involving patients with Giant Cell Arteritis, and is planning a Phase II trial in asthma.

The drug was filed in Europe in September last year.

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