Bausch Health group Ortho Dermatologics has resubmitted an application to market its plaque psoriasis lotion Duobrii in the US.
The move follows receipt of a complete response letter from the US Food and Drug Administration back in June, that raised questions regarding the drug’s pharmacokinetic data but did not specify any deficiencies relating to clinical efficacy or safety.
“After meeting with the FDA and understanding the additional pharmacokinetic data required for Duobrii, we have resubmitted the NDA ahead of schedule,” said Joseph Papa, Bausch Health’s (formerly Valeant) chairman and chief executive.
“We continue to have confidence in an approval of Duobrii and hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible.”
If approved, Duobrii will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adults.
Around 7.5 million in the US are thought to suffer from psoriasis, an inflammatory skin disease.