Bausch Health's plaque
psoriasis lotion gets tentative FDA approval
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[October 09, 2018]
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.
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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.
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"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.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Anil
D'Silva)
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