Concert Pharmaceuticals Maintains Deuruxolitinib Breakthrough Therapy Designation from FDA for the Treatment of Alopecia Areata
15 February 2023 - 11:00PM
Business Wire
Concert Pharmaceuticals, Inc. today announced that, after a
recent review of deuruxolitinib clinical data by the U.S. Food and
Drug Administration (FDA), the FDA determined that deuruxolitinib
will maintain its Breakthrough Therapy designation. Deuruxolitinib,
an oral Janus kinase (JAK) inhibitor, is being developed for the
treatment of adult patients with moderate to severe alopecia
areata.
In light of the FDA approval of a different JAK inhibitor as the
first treatment for alopecia areata, the FDA previously notified
Concert that it was reviewing the Breakthrough Therapy designation
previously granted for deuruxolitinib. At the FDA’s request,
Concert submitted additional clinical data and justification to
support the continued eligibility of deuruxolitinib for the
designation. The FDA has now informed Concert that, after reviewing
these data, the Breakthrough Therapy designation criteria continue
to be met at this time.
The FDA grants Breakthrough Therapy designation for drug
candidates that treat a serious or life-threatening condition where
preliminary clinical evidence indicates that the drug candidate may
demonstrate substantial improvement on a clinically significant
endpoint(s) over available therapies. Whether the improvement over
available therapy is substantial is a matter of judgment and
depends on both the magnitude of the treatment effect, which could
include duration of the effect, and the importance of the observed
clinical outcome. In general, the preliminary clinical evidence
should show a clear advantage over available therapy.
The FDA originally granted Breakthrough Therapy designation to
deuruxolitinib for the treatment of adult patients with moderate to
severe alopecia areata in 2020, which was supported by positive
data from a Phase 2 clinical trial. The additional information that
Concert submitted to support the continued maintenance of the
Breakthrough Therapy designation for deuruxolitinib included the
positive data from two Phase 3 clinical trials.
About Deuruxolitinib and Alopecia Areata
Deuruxolitinib is an investigational oral selective inhibitor of
Janus kinases JAK1 and JAK2. In addition to Breakthrough Therapy
designation for the treatment of adult patients with moderate to
severe alopecia areata, the FDA has granted deuruxolitinib Fast
Track designation for the treatment of alopecia areata.
Alopecia areata is an autoimmune disease in which the immune
system attacks hair follicles, resulting in partial or complete
loss of hair on the scalp and body. Alopecia areata may affect up
to approximately 1.5 million Americans at any given time.1 The
scalp is the most commonly affected area, but any hair-bearing site
can be affected alone or together with the scalp. Onset of the
disease can occur throughout life and affects both women and men.
Alopecia areata can be associated with serious psychological
consequences, including anxiety and depression. There are currently
limited treatment options available for alopecia areata.
About Concert
Concert Pharmaceuticals is a late-stage clinical
biopharmaceutical company that is developing deuruxolitinib
(CTP-543), a novel, deuterated, oral JAK1/2 inhibitor. Concert has
successfully completed two Phase 3 trials with deuruxolitinib in
adults with alopecia areata, a serious autoimmune dermatological
disease. The Company is also evaluating the use of deuruxolitinib
in other indications and assessing a number of earlier-stage
pipeline candidates. For more information, please visit
www.concertpharma.com or follow us on Twitter, Instagram or
LinkedIn.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future
expectations, plans and prospects, including, among others,
statements about our expectations regarding the development of
deuruxolitinib, and any other statements containing the words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “potential,” “predict,” “project,”
“should,” “target,” “will,” “would” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
uncertainties inherent in the initiation, timing and design of
future clinical trials, the availability and timing of data from
ongoing and future clinical trials and the results of such trials,
whether preliminary results, including safety profiles, from a
clinical trial will be predictive of the final results of that
trial or whether results of early clinical trials will be
indicative of the results of later clinical trials, expectations
for the timing of the submission of a New Drug Application, the
availability of regulatory approvals and other factors discussed in
the “Risk Factors” section of our most recent Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission and in
other filings that we make with the Securities and Exchange
Commission. In addition, any forward-looking statements included in
this press release represent our views only as of the date of this
release and should not be relied upon as representing our views as
of any subsequent date. We specifically disclaim any obligation to
update any forward-looking statements included in this press
release.
1 Benigno M. Clinical, Cosmetic and Investigational Dermatology
2020
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version on businesswire.com: https://www.businesswire.com/news/home/20230215005147/en/
For additional information: Justine Koenigsberg
(investors) Concert Pharmaceuticals, Inc. (781) 674-5284
ir@concertpharma.com
Kathryn Morris (media) The Yates Network (914) 204-6412
kathryn@theyatesnetwork.com
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