Pharmaceutical company Mayne Pharma Group Limited (ASX:MYX) on Wednesday announced the availability of LEXETTE (halobetasol propionate) Foam 0.05% in the US plaque psoriasis market.
LEXETTE is the conditionally-acceptable trade name for halobetasol foam and the new formulation of halobetasol, a potent topical corticosteroid indicated for the treatment of plaque psoriasis in adult patients. LEXETTE Foam has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
In conjunction, the company received the LEXETTE's approval from the US Food and Drug Administration (FDA) in May 2018, with three years of marketing exclusivity.
Additionally, LEXETTE Foam was evaluated for the treatment of moderate to severe plaque psoriasis in two multicentre, randomised, double-blind, vehicle-controlled studies. These studies were conducted in 560 subjects with plaque psoriasis involving between 2% and 12% body surface area, stated the company.
Plaque psoriasis affects approximately 7.5m Americans with potent topical corticosteroids prescribed to approximately 80% of psoriasis patients diagnosed. LEXETTE is part of the USD600m potent topical corticosteroid market for which 8m prescriptions are written annually.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial