PDUFA Action Date is Dec. 22,
2019
LAVAL, Quebec, Aug. 7, 2019 /CNW/ -- Bausch Health
Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho
Dermatologics, one of the largest prescription dermatology health
care businesses, today announced that the U.S. Food and Drug
Administration (FDA) has accepted the New Drug Application (NDA)
for IDP-123 (tazarotene 0.045%) Lotion with a PDUFA action date of
Dec. 22, 2019. If approved, IDP-123
will be the first tazarotene acne treatment available in a lotion
form.
"Millions of Americans are affected by acne and, for many of
these patients, it can be difficult to find a treatment that works
for them," said Bill Humphries,
president, Ortho Dermatologics. "If approved, IDP-123 will offer
physicians and their patients a lower concentration of tazarotene
in a lotion formulation, helping to further expand upon our growing
portfolio of acne treatments."
The NDA submitted for IDP-123 includes data from two
successfully completed Phase 3 randomized, placebo-controlled,
double-blind clinical trials in 1,614 patients with moderate to
severe acne. The primary efficacy endpoints included the absolute
change in the mean noninflammatory and inflammatory lesion counts,
the percentage of subjects who had a least a two-grade improvement
from baseline to week 12 in the Evaluator Global Severity Score
(EGSS) and who had "clear" or "almost clear" skin. In both
Phase 3 studies, all primary efficacy endpoints were met with
statistical significance (p<.001). IDP-123 was also shown to be
well-tolerated in the clinical study population. The most common
adverse events were application site pain, application site dryness
and application site exfoliation.
About Acne Vulgaris
Acne is the most common skin
problem in the United States,
which occurs when hair follicles become plugged with oil and skin
cells, often causing whiteheads, blackheads or pimples to appear on
the face, forehead, chest, upper back and shoulders. Up to 50
million Americans have acne.1 Depending on its severity,
acne can cause emotional distress and scar the
skin.2
About Ortho Dermatologics
Ortho Dermatologics is one
of the largest prescription dermatology businesses dedicated to
helping patients in the treatment of a range of therapeutic areas,
including psoriasis, actinic keratosis, acne, atopic dermatitis and
other dermatoses. The Ortho Dermatologics portfolio includes
several leading acne, anti-fungal and corticosteroid-responsive
dermatoses products. More information can be found at
www.ortho-dermatologics.com.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company
whose mission is to improve people's lives with our health care
products. We develop, manufacture and market a range of
pharmaceutical, medical device and over-the-counter products,
primarily in the therapeutic areas of eye health, gastroenterology
and dermatology. We are delivering on our commitments as we build
an innovative company dedicated to advancing global health. More
information can be found at www.bauschhealth.com.
Forward-looking Statements
This news release may contain forward-looking statements, which may
generally be identified by the use of the words "anticipates,"
"expects," "intends," "plans," "should," "could," "would," "may,"
"will," "believes," "estimates," "potential," "target," or
"continue" and variations or similar expressions. These statements
are based upon the current expectations and beliefs of management
and are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include,
but are not limited to, risks and uncertainties discussed in the
Company's most recent annual or quarterly report and detailed from
time to time in the Company's other filings with the Securities and
Exchange Commission and the Canadian Securities Administrators,
which factors are incorporated herein by reference. In addition,
certain material factors and assumptions have been applied in
making these forward-looking statements, including that the risks
and uncertainties outlined above will not cause actual results or
events to differ materially from those described in these
forward-looking statements. The Company believes that the material
factors and assumptions reflected in these forward-looking
statements are reasonable, but readers are cautioned not to place
undue reliance on any of these forward-looking statements. These
forward-looking statements speak only as of the date hereof. Bausch
Health undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this news release or to reflect actual outcomes, unless
required by law.
References
1. American Academy of Dermatology.
(2019). Skin conditions by the numbers. Retrieved from
https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers.
Accessed April 1, 2019.
2. Mayo Clinic. (2018). Acne. Retrieved from
https://www.mayoclinic.org/diseases-conditions/acne/symptoms-causes/syc-20368047.
Accessed April 1, 2019.
© 2019 Ortho Dermatologics' affiliated
entities.
AZO.0015.USA
Investor/Media Contact:
Arthur
Shannon
arthur.shannon@bauschhealth.com
(514) 856-3855
(877) 281-6642 (toll free)
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SOURCE Bausch Health Companies Inc.