Valeant Receives CRL For DUOBRII

Valeant Pharmaceuticals recently received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) for their DUOBRII, an experimental lotion to treat plaque psoriasis.

DUOBRII consists of a “high potency” steroid and the retinoid tazarotene, which produces a “synergistic effect" according to Valeant. DUOBRII is one of seven drugs that Valeant is projecting to generate over $1 billion in the next five years. The company has made psoriasis its target therapeutic area, and in February 2017, they received FDA approval for SILIQ, a drug used to cure moderate-to-severe psoriasis. However, SILIQ comes with a Black Box Warning because of patients who have committed suicide while using the drug.

The FDA’s rejection could cause delays for the drug’s launch. According to a press release, “The CRL did not specify any deficiencies related to the clinical efficacy or safety of DUOBRII and no issues with CMC* processes,” said Valeant CEO and Chairman, Joseph C. Papa. “The CRL only noted questions regarding pharmacokinetic data. 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."