FDA Votes in Favor of Brodalumab, But Cautions of Risks

July 20, 2016
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.

During a July 19, 2016 Dermatologic and Ophthalmic Drugs Advisory Committee, FDA panelists voted unanimously in favor of approving AstraZeneca and Valeant’s psoriasis drug brodalumab, but not without some stipulations. While the committee support the drug’s approval, 14 of the 18 members thought additional risk management options should be implemented, according to an analyst report from Evercore ISI.

During clinical trials, the IL-17 receptor targeting monoclonal antibody (mAb) displayed a potential link to suicidal ideation and behavior (SIB). An FDA report indicates of 5041 patients receiving the drug during trials, there were 11 individual suicide behavior and ideation events, four completed suicides, and three deaths from unknown causes from Oct. 2010 through Feb. 2014. Throughout all brodalumab programs, a total of six completed suicides were reported.

After reviewing these results, FDA requested Amgen, the drugs sponsor at the time, further evaluate the risk, the FDA report says. Amgen later announced it would no longer be co-developing the drug, and said it had plans to terminate clinical trials. In Nov. 2016, AstraZeneca submitted a biologics license application (BLA) for the treatment, and then transferred its commercialization rights to Valeant.

According to the Evercore ISI, several FDA panelists recommended additional data be reviewed to determine if there is in fact a link between SIB and brodalumab. Some committee members recommended a label warning, while others indicated there may be a need for a black box warning. Still, others noted the benefits of brodalumab may outweigh the risks.

In clinical trials brodalumab cleared skin plaques more efficiently than Johnson & Johnson’s Stelara (ustekinumab). Brodalumab is currently approved for use in the European Union and Japan, and will likely be approved in the US. If approved, the drug may be a direct competitor for Eli Lilly’s psoriasis treatment Taltz (ixekizumab) and Novartis’ Cosentyx (secukinumab).

Source: Valeant, FDA, Evercore ISI