Valeant Pharmaceutical’s quest for a turnaround after an arduous few months hit a potential roadblock.
The Food and Drug Administration (FDA) was unable to assess the full risk of suicide associated with the company’s psoriasis drug called brodalumab after conducting a preliminary review.
The agency cited limited control data being responsible for the difficulty in evaluating the risk of suicide with this drug.
Brodalumab, an interleukin-17 inhibitor, is linked with six suicides in three different Phase 3 clinical trials: 4 in psoriasis, 1 in rheumatoid arthritis, and one in psoriatic arthritis. One suicide “was later adjudicated as indeterminate due to possible accidental drug overdose,” according to the FDA’s review.
Two of the patients in this group had a history of either substance abuse or psychiatric disorders and treatment whereas the other four had no apparent history. Ages varied between 39 and 58, but the review panel still found it difficult to reach a solid conclusion related to brodalumab’s effect on their mental state.
The documents also explained the sponsor of these clinical trials terminated them early making it more difficult for the organization to judge brodalumab’s safety risks.
“From the available data, we cannot conclude whether or not suicide is a drug-related risk,” wrote the agency in their review.
Brodalumab was developed through a partnership between AstraZeneca and Amgen, reported Reuters.
Amgen withdrew from the collaboration in May 2015 upon news of the suicides, but AstraZeneca later licensed the global rights to Valeant. The embattled Canadian company has struggled to correct itself after critics scrutinized the firm’s policies for drug pricing and its relationship with a specialty pharmacy.
AstraZeneca predicted brodalumab could eventually produce annual sales of up to $1.5 billion a year, according to Reuters.
However, this news could complicate the drug’s chances. An FDA advisory panel composed of outside experts will meet in the next two days to decide on whether the drug should be recommended for approval.
Filed Under: Drug Discovery
