U.S. regulators had differing opinions on the risk of Valeant Pharmaceuticals International Inc.’s experimental psoriasis treatment and recommended, if approved for sale, that it possibly include a warning that it may be linked to suicidal thoughts and behavior or that the company conduct new clinical trials to better understand the risks.
The drug, brodalumab, works to treat moderate to severe plaque psoriasis, yet the safety issues are complex, according to areport released Friday by Food and Drug Administration staff. FDA advisers will consider the report and data from Valeant when they meet Tuesday to consider whether the drug should be approved with only a warning label or other methods to restrict use as well.
FDA staff also raised questions about whether brodalumab may be linked to major adverse cardiovascular events, such as heart attack or stroke. Six suicides occurred in clinical trials of brodalumab, though one may have been due to possible accidental drug overdose, according to the report.
Because of the complexity of the safety review, eight FDA divisions were involved. The division of pharmacovigilance questioned whether the suicides could be linked to brodalumab given that “patients with psoriasis have a particularly high rate of psychiatric morbidity, including depression, anxiety, suicidal ideation and suicidal behavior, substance use disorders, and other psychiatric disorders. Furthermore, the prevalence of mood symptoms in psoriasis is higher than that observed in many other disfiguring skin disorders.” The division still recommended a label that describes the potential suicide risk with an emphasis on the fact that it is not “an established drug risk.”
Valeant paid $100 million to acquire the commercial rights to the drug from AstraZeneca Plc in September. Amgen Inc. had previously ended its brodalumab collaboration with AstraZeneca when it appeared the medication may require a warning on suicide risk, which likely would limit sales. The FDA is expected to decide whether to approve brodalumab for sale by Nov. 16.
Valeant was the target of congressional investigations earlier this year for sharply raising the price on older medications it acquired to increase profits. Amid the turmoil and the company’s plummeting stock, Chief Executive Officer Joseph Papa replaced Michael Pearson in the top spot.
Valeant’s psoriasis drug targets receptors in the body that respond to groups of proteins called IL-17. By stopping IL-17 from activating the receptor, brodalumab prevents the body from inducing an inflammatory response, according to Valeant.
The FDA has approved similar drugs recently, one from Novartis AG in January 2015 called Cosentyx and another from Eli Lilly & Co. in March called Taltz, which don’t have issues with suicidal thoughts. Cosentyx generated $261 million in sales in 2015, a number that is expected to rise to $1.37 billion in 2017, according to analysts’ estimates compiled by Bloomberg.
Psoriasis affects about 7.5 million Americans, according to the American Academy of Dermatology, and can cause patches of raised, red and scaly skin. Valeant is seeking to treat patients with moderate to severe plaque psoriasis, the most common form of the condition.