FDA rejects approval of Valeant's Duobrii for plaque psoriasis over pharmacokinetic data

Valeant Pharmaceuticals' Ortho Dermatologics unit reported Monday that the FDA issued a complete response letter regarding a filing seeking approval of Duobrii (halobetasol propionate/tazarotene) lotion for the treatment of plaque psoriasis. Valeant CEO Joseph Papa said the letter "did not specify any deficiencies related to the clinical efficacy or safety of Duobrii," and that it "only noted questions regarding pharmacokinetic data." The company's shares fell as much as 7 percent on the news.

The treatment, also known as IDP-118, was submitted for FDA approval last year, with the agency accepting the filing in November. Phase III study data unveiled in January 2017 showed that Duobrii was linked to a significantly higher rate of treatment success, defined in part as the achievement of a "clear" to "almost clear" skin score, versus vehicle in adults with moderate-to-severe psoriasis who received eight weeks of treatment followed by four weeks of follow-up. 

FirstWord reports in this therapy area - KOL Insight Psoriasis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more. 

Papa stated "we are working to resolve this matter expeditiously and have already requested a meeting with the FDA." The CEO had previously identified Duobrii as one of seven developmental products with the potential to generate more than $1 billion in revenue. 

Commenting on the complete response letter, Wells Fargo analyst David Maris remarked "we wonder if Valeant will need to update this expectation for the 'Significant Seven' peak sales following the setback to Duobrii." He added "we suspect that Duobrii is no longer a 2018 launch, as Valeant had previously guided, and may not even be a 2019 event." 

Last month, Valeant announced plans to change its name to Bausch Health Companies as of July. 

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