(Reuters) – Bausch Health Cos Inc, formerly Valeant Pharmaceuticals, said on Monday it received tentative U.S. approval to market its plaque psoriasis lotion, Bryhali.
The company plans to launch the lotion in November after receiving final approval from the Food and Drug Administration, pending expiration of exclusivity for a related product, Bausch said in a statement.
The FDA’s tentative approval comes after a similar treatment from the company failed to win clearance in June.
Plaque psoriasis is a chronic condition that causes dry, red skin lesions covered with silvery scales.
In clinical trials, Bausch’s treatment was generally well-tolerated with no increase in epidermal atrophy – thinning or depression of skin due to reduction of underlying tissue – when applied once daily for eight weeks, the company said.
Although topical steroids are frequently used for psoriasis, their long-term use have been limited due to serious side effects such as epidermal atrophy, which was seen in Bristol-Myers Squibb’s Ultravate after two weeks of treatment.
“It is still unclear if Bryhali will be labeled for longer-term use, but we are encouraged by the press release which hints at tolerability benefits over Ultravate and a longer dosing regimen,” Mizuho analyst Irina Koffler said in a note.
Mizuho said it estimated Bryhali to bring in revenue of $68 million in 2022, while expecting the lotion to help reach the company’s target of doubling the dermatology business over the next five years.
U.S.-listed shares of Bausch rose 2.2 percent to $26.90 before the bell.
OCTOBER 8, 2018