FDA reviewers cite safety concerns regarding Johnson & Johnson's experimental RA drug Plivensia

According to FDA documents released Monday ahead of an advisory panel meeting on August 2, agency staff signalled a "trend of increased overall mortality" for Johnson & Johnson's experimental rheumatoid arthritis (RA) drug Plivensia (sirukumab) versus placebo, with common causes of death being major adverse cardiovascular events, infection and malignancy. FDA staff pointed out that while potential safety issues related to immunosuppression were similar to other products targeting the IL-6 pathway, the higher mortality trend "seems unique for the [Plivensia] programme."

The reviewers said studies submitted to support the regulatory filing demonstrated that the two tested doses of Plivensia were similarly effective versus placebo, but neither dose was superior to AbbVie's Humira (adalimumab). Johnson & Johnson's former partner GlaxoSmithKline unveiled positive data in 2015 from the programme's Phase III SIRROUND-D, SIRROUND-H and SIRROUND-T trials. Johnson & Johnson later reported that the SIRROUND-D study had met its co-primary endpoints versus placebo by inhibiting radiographic progression from baseline to week 52, as well as improving signs and symptoms of RA at week 16.

The marketing application for Plivensia seeks to have the injectable drug approved for adults with moderately to severely active RA who have an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs. Johnson & Johnson spokesperson Brian Kenney cautioned that RA is a complex disease that can require patients to attempt multiple treatments before identifying an effective option. "We are confident in the benefit-to-risk of sirukumab," he added. 

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Commenting on the news, Morningstar analyst Damien Conover suggested that neither Plivensia, nor Sanofi and Regeneron Pharmaceuticals' RA therapy Kevzara (sarilumab), which the FDA recently approved in the same indication, are sufficiently different from Roche's Actemra (tocilizumab) to gain significant market share. "I don't think they are really going to move the needle for any of these large companies," Conover stated. Analysts are forecasting Plivensia sales to be about $450 million by 2020, if approved, while Kevzara is projected to reach roughly $667 million over the same period.

GlaxoSmithKline disclosed in its most recent quarterly results presentation that it would return full rights to Plivensia to Johnson & Johnson as the UK company looks to streamline its drug research operations. In May, Johnson & Johnson identified the treatment as one of more than 10 drugs with blockbuster potential that it plans to launch or submit for approval by 2021. 

Plivensia is currently under review in Europe and in Japan

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