Ulobetasol

Unassigned

New Medicines

Bryhali, Jemdel · Plaque psoriasis - lotion formulation

Information

Bryhali, Jemdel
New molecular entity
Not Known
Ortho Dermatologics

Development and Regulatory status

None
None
Approved (Licensed)

Nov 18: Approved in the US for topical treatment of plaque psoriasis based on results of two trials. Launch planned for Nov 18 [2].


Feb 18: Filing accepted in the US for ulobetasol (halobetasol propionate) 0.01% lotion [2].

Category

Topical corticosteroid. Ulobetasol is believed to work through the inhibition of phospholipase A2 which is involved in inflammatory processes associated with psoriasis
Prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Men and women are equally affected. It can occur at any age but the majority of cases first present before the age of 35 years. It is uncommon in children. Plaque psoriasis accounts for 90% of all people with psoriasis [1].
Plaque psoriasis - lotion formulation
Topical

Trial or other data

May 17: PIII study that assessed the safety and efficacy of topical lotion of ulobetasol in 217 patients with moderate to severe plaque psoriasis in the US (NCT02514577) [2].


Apr 17: PIII study that assessed the safety and efficacy of topical lotion of ulobetasol in 213 adults with moderate to severe plaque psoriasis in the US completes (NCT02515097) [2].