A U.S. Food and Drug Administration advisory committee voted against the approval of Johnson & Johnson's experimental rheumatoid arthritis drug sirukumab.
The committee believes the drug should not be approved because its benefits do not outweigh its risks, Reuters reported Aug. 2.
The panelists reportedly voted 12-1 against the drug, echoing the analysis of FDA staff reviewers who previously said the drug had higher rates of death and cancers versus placebo in studies.
Analysis disclosed that sirukumab had a higher rate of major adverse cardiovascular events, such as non-fatal heart attacks and strokes, in addition to cardiovascular death, in Johnson & Johnson's studies of the drug at the 50 mg dosage. But those events were not more frequent in patients who got the 100 mg dosage.
The committee members also pointed out that there are already two other drugs on the market in the same class — Roche Holding AG's Actemra and Sanofi and Regeneron Pharmaceuticals Inc.'s Kevzara.
"There is no reason to think that this new drug will act in a tremendously different way," Reuters reported, citing Maria Suarez-Almazor, rheumatology section chief at the University of Texas MD Anderson Cancer Center.
Johnson & Johnson had been collaborating with GlaxoSmithKline plc on the drug. The latter recently terminated the partnership and said it would return all rights to Johnson & Johnson.
The FDA usually follows the recommendations of its panel but is not obligated to do so.
"We are disappointed and disagree with the group's interpretation of the sirukumab benefit-to-risk profile," said Newman Yeilding, head of immunology development at the company's Janssen unit.
He added that the company remains confident in the data accumulated to date supporting the drug as a treatment of moderately to severely active rheumatoid arthritis and looks forward to continuing discussions with the regulator in their review of the application.