Agile Therapeutics Announces FDA Extension of Twirla® NDA Review Period
November 14 2019 - 4:30PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare
company, today announced that the U.S. Food and Drug Administration
(FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal
date for its review of the New Drug Application (NDA) of Twirla®
(levonorgestrel/ethinyl estradiol) transdermal system, an
investigational combined hormonal contraceptive patch, from
November 16, 2019 to February 16, 2020.
On October 30, 2019, the FDA’s Bone, Reproductive, and Urologic
Drugs Advisory Committee (BRUDAC) met to discuss the benefits and
risks of Twirla and voted 14 to 1, with one abstention, that the
benefits of Twirla (AG200-15) in the prevention of pregnancy
outweigh the risks to support approval. Although the FDA
considers the non-binding recommendation of this panel, the final
decision regarding the approval of the product is made by the FDA
alone.
After the BRUDAC meeting, at the FDA’s request, Agile submitted
additional information to the NDA concerning topics discussed at
the BRUDAC meeting. FDA determined that these submissions
constitute a major amendment and will take additional time to
review. According to FDA’s current PDUFA Performance Goals,
an FDA decision to extend the review period typically is limited to
situations where review of the new information could address an
outstanding issue(s) and potentially lead to approval in the
current review cycle.
“We look forward to continuing our discussions
with the FDA,” said Al Altomari, Chairman and Chief Executive
Officer of Agile. “We remain committed to bringing this important
contraceptive option to women.”
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, 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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