Bausch Health's plaque psoriasis lotion gets tentative FDA approval
By Saumya Joseph
(Reuters) - Bausch Health Cos Inc, formerly Valeant Pharmaceuticals, said on Monday it received tentative U.S. approval to market its plaque psoriasis lotion, Bryhali (halobetasol propionate), for use in adults.
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.
In clinical trials, Bausch's treatment was generally well-tolerated with no increase in epidermal atrophy 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.(c) Copyright Thomson Reuters 2018. Click For Restrictions - https://agency.reuters.com/en/copyright.html