Bausch's (BHC) Arazlo Gets FDA Approval For Acne Vulgaris
Zacks Investment Research | Dec 19, 2019 09:28PM ET
Bausch Health Companies Inc.’s (NYSE:BHC) dermatology business, Ortho Dermatologics, announced that the FDA has approved the New Drug Application for its acne lotion Arazlo (tazarotene).
Arazlo Lotion 0.045% has been approved for the topical treatment of acne vulgaris in patients nine years of age or older.
The approval was based on two phase III multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate-to-severe acne. In both studies, all primary efficacy endpoints were met with statistical significance. Arazlo was also generally well-tolerated in the clinical study population.
The approval will broaden Bausch’s dermatology portfolio, expanding its acne portfolio to help approximately 50 million Americans who are affected by this prevalent skin condition. Per the company, Arazlo is the first tazarotene acne treatment available in a lotion form.
The Ortho Dermatologics business comprises treatments for a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The business consists of Duobrii, Bryhali and Siliq product lines as well.
Bausch is on track to build its psoriasis and acne product portfolios, with a focus on topical gel and lotion products over injectable biologics as they promise potential. The company recently expanded its Ortho Dermatologics sales force to drive growth.
Bausch’s stock has surged 61.9% in the year so far compared with the Original post
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