Sage Therapeutics Receives Fast Track Designation for SAGE-217 for the Treatment of Major Depressive Disorder
May 18 2017 - 7:00AM
Business Wire
Sage Therapeutics (NASDAQ: SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track Designation to SAGE-217 for development as a
potential treatment for major depressive disorder (MDD). Fast Track
is a process designed to facilitate the development and review of
new treatments for serious conditions with unmet medical need such
as MDD.
“The FDA Fast Track Designation is an important milestone in the
development of SAGE-217, as it provides opportunities to
potentially accelerate clinical development and future regulatory
review of SAGE-217 for the treatment of MDD,” said Amy Schacterle,
Ph.D., Senior Vice President, Regulatory Affairs and Quality
Assurance of Sage. “Our discussions with regulatory agencies
continue to focus on determining the most appropriate and efficient
pathways for bringing new therapies to patients.”
About Fast Track Designation
Fast Track is a process designed to facilitate the development,
and expedite the review, of drugs to treat serious conditions and
fill an unmet medical need. Drugs that receive Fast Track
designation may be eligible to be the subject of more frequent
communications and meetings with FDA to review the drug's
development plan including the design of the proposed clinical
trials, use of biomarkers and the extent of data needed for
approval. Drugs with Fast Track Designation may also qualify for
priority review to expedite the FDA review process, if relevant
criteria are met.
The purpose is to get important new drugs to the patient
earlier. Fast Track addresses a broad range of serious conditions.
For more information about Fast Track, please
visit:https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.
About SAGE-217
Sage's most advanced, oral product candidate is SAGE-217, a
novel, orally-active neuroactive steroid that is a positive
allosteric modulator of synaptic and extrasynaptic GABAA receptors.
The GABA system is the major inhibitory signaling pathway of the
brain and CNS, and contributes significantly to regulating CNS
function. SAGE-217 is currently in Phase 2 development in both
mood and movement disorders, with four Phase 2 clinical programs
now underway.
About Major Depressive Disorder
Major depression disorder (MDD) is a common but serious mood
disorder in which patients exhibit depressive symptoms, such as a
depressed mood or a loss of interest or pleasure in daily
activities consistently for at least a two-week period, and
demonstrate impaired social, occupational, educational or other
important functioning. Approximately 16 million people in
the U.S. suffer from MDD each year.1 While
antidepressants are widely used for treatment, large scale studies
have demonstrated the need for additional therapies.2,3
About Sage Therapeutics
Sage Therapeutics is a clinical-stage biopharmaceutical
company committed to developing novel medicines to transform the
lives of patients with life-altering central nervous system (CNS)
disorders. Sage has a portfolio of novel product candidates
targeting critical CNS receptor systems, GABA and NMDA. Sage's lead
program, brexanolone (SAGE-547), is in Phase 3 clinical development
for super-refractory status epilepticus, a rare and severe seizure
disorder, and for postpartum depression. Sage is developing its
next generation modulators, including SAGE-217 and SAGE-718, in
various CNS disorders. For more information, please
visit www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation:
our statements as to the potential for expedited development and
review for SAGE-217 in MDD as a result of Fast Track designation;
our expectations regarding further development and the potential of
SAGE-217 in the treatment of MDD; our view of the potential of the
GABA mechanism and our product candidates in the treatment of CNS
diseases and disorders; and our views as to the unmet need for
additional treatment options in MDD and estimated number of
patients with MDD. These forward-looking statements are neither
promises nor guarantees of future performance, and are subject to a
variety of risks and uncertainties, many of which are beyond our
control, which could cause actual results to differ materially from
those contemplated in these forward-looking statements, including
the risks that: we may not achieve expedited development or review
of SAGE-217 as a result of Fast Track designation; decisions or
actions of the FDA or other regulatory agencies may
affect the initiation, timing, design, size, progress and cost of
clinical trials and our ability to proceed with further clinical
trials of a product candidate; we may not be able to successfully
demonstrate the efficacy and safety of SAGE-217 or any of our other
product candidates at each stage of development; success in early
stage clinical trials may not be repeated or observed in ongoing or
future studies involving the same compound or other product
candidates; and ongoing and future clinical results may not support
further development of a product candidate or be sufficient to gain
regulatory approval to market any product; we may decide that a
development pathway for one of our product candidates in one or
more indications is no longer feasible or advisable or that the
unmet need no longer exists; the actual size of the MDD patient
population may be significantly lower than our estimates and, even
if SAGE-217 is successfully developed and approved for MDD, it may
only be approved or used to treat a subset of the MDD population;
and we may encounter technical and other unexpected hurdles in the
development and manufacture of our product candidates; as well as
those risks more fully discussed in the section entitled "Risk
Factors" in our most recent Quarterly Report on Form 10-Q, as well
as discussions of potential risks, uncertainties, and other
important factors in our subsequent filings with
the Securities and Exchange Commission. In addition, any
forward-looking statements represent our views only as of today,
and should not be relied upon as representing our views as of any
subsequent date. We explicitly disclaim any obligation to update
any forward-looking statements.
1 Nat. Inst. of Mental Health website, 2015; Available
at https://www.nimh.nih.gov/health/statistics/prevalence/major-depression-among-adults.shtml.
2 Trivedi MH et al. Evaluation of Outcomes with Citalopram
for Depression using Measurement-Based Care in STAR*D: Implications
for Clinical Practice. Am J Psychiatry, 2006,163:1, 28-40. doi:
10.1176/appi.ajp.163.1.28.
3 Rush AJ et al. Acute and Longer-Term Outcomes in
Depressed Outpatients Requiring One or Several Treatment Steps: A
STAR*D Report. Am J. Psychiatry, 2006,163:11, 1905-1917. doi:
10.1176/ajp.2006.163.11.1905.
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version on businesswire.com: http://www.businesswire.com/news/home/20170518005163/en/
Investor Contact:Sage TherapeuticsPaul Cox,
617-299-8377paul.cox@sagerx.comorMedia Contact:Suda
Communications LLCMaureen L. Suda,
585-387-9248maureen.suda@sagerx.com
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