Bausch Health's Ortho Dermatologics unit on Thursday announced that the FDA has approved Duobrii (halobetasol propionate/tazarotene) lotion for the topical treatment of adults with plaque psoriasis. Ortho Dermatologics president Bill Humphries remarked "we believe that Duobrii has the potential to delay some patients from switching to more expensive biologic treatments, which could potentially result in health care savings."
Bausch Health's submission of the drug was backed by safety and efficacy data from two Phase III studies. In study results unveiled in 2017, Duobrii was found to significantly increase the rate of "clear" to "almost clear" skin versus placebo.
Bausch Health indicated that Duobrii, previously known as IDP-118, will be priced at $825 for a 100-gram tube, which it said is "more than 50 percent lower than other branded topical combination products". The drugmaker plans to launch the treatment in the US in June.
Approval of the drug comes after the FDA declined to clear the therapy in June 2018 after questioning pharmacokinetic data. The agency accepted Bausch Health's re-submission of the filing seeking approval of the drug last August.
Bausch Health CEO Joseph Papa has previously identified Duobrii as one of seven investigational assess with the potential to amass more than $1 billion in revenue. Authorisation of the drug comes after Bausch Health's Bryhali (halobetasol propionate) was approved by the FDA for the treatment of plaque psoriasis last November, with a US launch planned that same month.
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