Agile Therapeutics Announces Favorable Outcome of FDA Advisory Committee Meeting for its Investigational Transdermal Contrace...
October 30 2019 - 6:33PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare
company, announced a positive outcome from today’s meeting of the
Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC)
of the U.S. Food and Drug Administration (FDA). The BRUDAC met to
discuss the Company’s New Drug Application (NDA) for its lead
product candidate, Twirla® (AG200-15), an investigational combined
hormonal contraceptive patch.
The BRUDAC voted 14 to 1, with 1 abstention,
that the benefits of Twirla (AG200-15) in the prevention of
pregnancy outweigh the risks to support approval.
“We are very pleased that BRUDAC voted in favor
of Twirla. We look forward to continuing our dialogue with the FDA
about the important data presented today and working toward a
potential approval of Twirla,” said Al Altomari, Chairman and Chief
Executive Officer of Agile. “This vote represents a key step toward
providing an important new contraceptive option for women.”
Agile resubmitted the NDA for Twirla (AG200-15)
on May 16, 2019. The advisory committee’s non-binding vote is taken
into consideration by the FDA as part of its evaluation of the NDA.
The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal
date of November 16, 2019, for the completion of its review of the
Twirla (AG200-15) NDA.
About
Twirla® (AG200-15)Twirla
(levonorgestrel/ethinyl estradiol transdermal
system) or AG200-15 is an
investigational, once-weekly combined
hormonal contraceptive (CHC) patch that contains the active
ingredients ethinyl estradiol (EE), a type of estrogen, and
levonorgestrel (LNG), a type of progestin. Twirla is designed to be
applied once weekly for three weeks, followed by a week without a
patch. The Company has completed its Phase 3 clinical trials of
Twirla and is pursuing regulatory approval in the U.S. after
resubmitting a New Drug Application (NDA) for Twirla on May 16,
2019.
About Agile Therapeutics,
Inc.Agile Therapeutics is a forward-thinking women's
healthcare company dedicated to fulfilling the unmet health needs
of today’s women. Our product candidates are designed to provide
women with contraceptive options that offer freedom from taking a
daily pill, without committing to a longer-acting method. Our lead
product candidate, Twirla® (levonorgestrel/ethinyl estradiol
transdermal system), also known as AG200-15, is an investigational,
non-daily prescription contraceptive. Twirla is based on our
proprietary transdermal patch technology, called Skinfusion®, which
is designed to allow drug delivery through the skin. For more
information, please visit the company website at
www.agiletherapeutics.com. The Company may occasionally
disseminate material, nonpublic information on the Company’s
website.
Forward-Looking
StatementCertain information contained in this press
release includes “forward-looking statements”, within the meaning
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended,
related to our regulatory submissions for Twirla. We may, in some
cases use terms such as “predicts,” “believes,” “potential,”
“continue,” “anticipates,” “estimates,” “expects,” “plans,”
“intends,” “may,” “could,” “might,” “likely,” “will,” “should” or
other words that convey uncertainty of the future events or
outcomes to identify these forward-looking statements. Our
forward-looking statements are based on current beliefs and
expectations of our management team that involve risks, potential
changes in circumstances, assumptions, and
uncertainties, including statements
regarding the approvability and
subsequent availability of Twirla,
the interpretation of data that supports the approval of
Twirla, and the timing of the FDA’s review of the Twirla NDA.
Any or all of the forward-looking statements may turn out to be
wrong or be affected by inaccurate assumptions we might make or by
known or unknown risks and uncertainties. These forward looking
statements are subject to risks and uncertainties including risks
related to our ability to adequately respond to the deficiencies in
the second Twirla CRL issued by the FDA on December 21, 2017, the
potential that the FDA determines that our data do not support
approval of the Twirla NDA and requires us to conduct additional
studies or reformulate Twirla to address the concerns raised in the
2017 CRL, our ability to obtain and maintain regulatory approval of
Twirla, the inability of our third-party manufacturer, Corium
International, Inc. (Corium), to complete any work or provide any
data and other information necessary to support the approval of our
Twirla NDA, our ability along with Corium to complete successfully
the scale-up of the commercial manufacturing process for Twirla,
including the qualification and validation of equipment related to
the expansion of Corium's manufacturing facility and to receive a
favorable result on the FDA pre-approval inspection, the
performance and financial condition of Corium or any of the
suppliers to our third-party manufacturer, the success and timing
of our clinical trials or other studies, regulatory and legislative
developments in the United States and foreign countries, our
ability to obtain and maintain intellectual property protection for
Twirla, our inability to timely obtain from our third-party
manufacturer, Corium, sufficient quantities or quality of our
product candidates or other materials required for a clinical trial
or other tests and studies, and the other risks set forth in our
filings with the U.S. Securities and Exchange Commission, including
our Annual Report on Form 10-K and our Quarterly Reports on Form
10-Q. For all these reasons, actual results and developments could
be materially different from those expressed in or implied by our
forward-looking statements. You are cautioned not to place undue
reliance on these forward-looking statements, which are made only
as of the date of this press release. We undertake no obligation to
publicly update such forward-looking statements to reflect
subsequent events or circumstances.
Source: Agile Therapeutics
Contact: Investor Relations --
609-683-1880
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