Agile Therapeutics Announces FDA Advisory Committee Meeting for its Investigational Transdermal Low-Dose Contraceptive Patch,...
24 Junho 2019 - 5:15PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare
company, today announced that a meeting of the Bone, Reproductive
and Urologic Drugs Advisory Committee of the U.S. Food and Drug
Administration (FDA) has been scheduled for October 30, 2019, to
review the Company’s New Drug Application (NDA) for its lead
product candidate, Twirla® (AG200-15), an investigational
low-dose combined hormonal contraceptive patch. Agile
resubmitted the NDA for Twirla (AG200-15) on May 16, 2019, and 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.
“We look forward to the October 30, 2019,
meeting with the Advisory Committee, as well as to continuing our
dialogue with the FDA about Twirla and the important data, which we
believe supports its approval,” said Al Altomari, Chairman and
Chief Executive Officer of Agile. “This is another key step towards
providing an important contraceptive option for women
today.”
About Twirla® (AG200-15)Twirla
(levonorgestrel/ethinyl estradiol transdermal system) or AG200-15
is an investigational low-dose, 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 low-dose, 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 our Advisory Committee meeting and 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,
our ability to obtain a favorable Advisory Committee vote, 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 pass a likely 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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