Halobetasol propionate + tazarotene

Unassigned

New Medicines

Duobrii · Plaque psoriasis

Information

Duobrii
New molecular entity
Bausch Health Companies
Bausch Health Companies

Development and Regulatory status

None
None
Pre-registration (Filed)
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]