FDA rejects Valeant plaque psoriasis lotion over pharmacokinetic concerns

Beleaguered pharma firm Valeant has come up against another bump in the road as its plaque psoriasis lotion Duobrii (halobetasol propionate and tazarotene) was rejected for US approval by the FDA.

The decision could prove to be a significant setback for the firm, who had placed heavy expectations on the drug; Duobrii is one of seven products in Valeant’s pipeline which it predicts will break $1 billion in sales over the next five years. Valeant’s shares fell by 7.1% on the news of the rejection.

Analysts are now questioning whether this sales forecast will be reviewed, and whether Duobrii will still see approval this year as planned, or even by the end of 2019. It was originally accepted for review back in November last year.

The FDA is thought to have turned down the drug due to concerns over its pharmacokinetic data, which covers the effects of a treatment on the body and its duration and intensity of effect.

"The CRL did not specify any deficiencies related to the clinical efficacy or safety of Duobrii and no issues with CMC processes. The CRL only noted questions regarding pharmacokinetic data," remarked Joseph C Papa, Chairman and CEO of Valeant. "We are working to resolve this matter expeditiously and have already requested a meeting with the FDA. We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible."