dm+d

Unassigned

New Medicines

DuobriiPlaque psoriasis

Information

Duobrii
New molecular entity
Bausch Health Companies
Bausch Health Companies

Development and Regulatory status

None
None
Launched
Jan 22Nothing to suggest plans to licence in the EU or UK [8].

Jun 19: Launched in the US [7].


Apr 19: Approved in US [6].


Aug 18: NDA resubmitted in US with additional pharmacokinetic data [5]


Jun 18: FDA CRL noted questions regarding pharmacokinetic data. Valeant Pharmaceuticals have requested a meeting with the FDA to discuss. [4]


Nov 17: Ortho Dermatologics, a division of Valeant Pharmaceuticals International announced that the US FDA has accepted the NDA IDP-118 (halobetasol propionate and tazarotene) lotion with a PDUFA action date of June 18, 2018. [2]


Sep 17: The company submitted the NDA to US FDA. [1,2]

Category

Combination of steroid and retinoid topical therapy
Estimated UK prevalence of psoriasis is about 1.3 - 2.2%, plaque psoriasis accounting for 90% [3].
Plaque psoriasis
Topical

Trial or other data

Sep 17: Filing was based on data from two PIII multi-centre randomised, double-blind clinical trials in 418 pts >18 years who had 3-12% of their body surface affected by plaque psoriasis. In both trials, the compound met the primary efficacy endpoint of “clear” to “almost clear” score at least a 2-grade improvement based on an Investigator Global Assessment (IGA) at 8 weeks, and a “clear” to “almost clear” and at least a 2-grade improvement during a 4-week follow-up visit at week 12. The NDA also had data from a long-term safety study involving pts followed up after a year. The most common adverse events were contact dermatitis (7.4%) and application site pain (2.6%). The PIII programme was preceded by a successful PII study where the treatment success rate with IDP-118, was 52.5%, which was superior to each of the components (halobetasol propionate and tazarotene) alone. This demonstrated, that the IDP-118 formulation is superior to the components separately.[2]