Last week Valeant (VRX) received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) pursuant to a New Drug Application (“NDA”) for Duobrii (halobetasol propionate and tazarotene) (IDP-118) lotion in the treatment of plaque psoriasis:
“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,” said Joseph C. Papa, chairman and CEO, 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.”
Valeant’s management believes the fact that the CRL did not specify any deficiencies related to efficacy or safety could be a silver lining; the CRL only noted issues related to pharmacokinetic data. Valeant is working to resolve the matter as expeditiously as possible and has sought a meeting with the FDA. How long it will take before Valeant resolves the FDA’s issues and attempts to relaunch the drug remain to be seen.
In my opinion, the jury is still out on the implications of the CRL on Duobrii’s chances of receiving FDA approval. According to Shocking The Street, a premium investment service the Shock Exchange runs with Seeking Alpha, the Duobrii debacle is foreboding for two reasons. Read more: