Johnson & Johnson announced Wednesday that an FDA advisory panel voted against recommending approval of its experimental rheumatoid arthritis (RA) therapy Plivensia (sirukumab). Citing safety concerns, the panel voted 12 to 1 that the benefits of the drug do not outweigh the risks.
According to Johnson & Johnson, the panel vote, which comes after FDA staff expressed safety concerns about Plivensia, was based on data from Phase III clinical development programme consisting of five studies involving more than 3000 patients with RA. Data from three clinical studies released in 2015 demonstrated positive results of the therapy, while additional study data unveiled the following year showed that the drug improved RA symptoms versus placebo.
Newman Yeilding, head of immunology at Johnson & Johnson's Janssen Research & Development unit, remarked "while the committee voted unanimously in support of the efficacy data, there was uncertainty regarding the safety profile," continuing "we are disappointed and disagree with the group's interpretation of the sirukumab benefit-to-risk profile."
Earlier this year, Johnson & Johnson cited Plivensia as one of more than 10 potential blockbuster treatments it hopes to launch or submit for regulatory clearance by 2021. The drugmaker regained full rights to the therapy after GlaxoSmithKline announced plans to abandon development of the treatment as part of its initiative to streamline its operations.
The marketing application with the FDA seeking approval of Plivensia for use in adults with moderately to severely active RA was submitted in September last year. The experimental human anti-IL-6 monoclonal antibody remains under review in Europe and in Japan.
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