Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today
that the U.S. Food and Drug Administration (FDA) provided an update
on its review of the New Drug Application (NDA) for YUTREPIA™
(treprostinil) inhalation powder to treat pulmonary arterial
hypertension (PAH) and pulmonary hypertension associated with
interstitial lung disease (PH-ILD). The FDA informed the Company
that it is confirming the process for adding the PH-ILD
indication as an amendment to the NDA for YUTREPIA.
Accordingly, the FDA is not able to issue an action letter in time
to meet the previously issued Prescription Drug User Fee Act
(PDUFA) goal date of January 24, 2024, and their review remains
ongoing. The FDA did not request any additional clinical data to
support the NDA and did not issue a new PDUFA goal date.
Dr. Roger Jeffs, Chief Executive Officer, said: “We are in
active communication with the FDA regarding the process we followed
to amend our NDA to add PH-ILD to the labeled
indication. Whether the NDA is amended or supplemented, we
will continue to prepare for the final FDA approval of YUTREPIA to
treat both PAH and PH-ILD patients following the expiration of
regulatory exclusivity for Tyvaso® on March 31, 2024. As
communicated by the tentative approval to treat PAH, YUTREPIA has
already met the regulatory standards for quality, safety and
efficacy. We remain committed to addressing the unmet needs across
all patients whose lives may be improved by the unique benefits of
YUTREPIA.”
On November 5, 2021, the FDA issued a tentative approval for
YUTREPIA for the treatment of PAH to improve exercise ability in
adult patients with New York Heart Association (NYHA) Functional
Class II-III symptoms. In July 2023, Liquidia filed an amendment to
its New Drug Application for YUTREPIA, seeking to add PH-ILD to the
label. The FDA previously confirmed that YUTREPIA may include the
treatment of PH-ILD to the proposed label for YUTREPIA without
additional clinical studies.
YUTREPIA also remains subject to ongoing litigation. Liquidia
filed a request for Judge Andrews of the U.S. District Court for
the District of Delaware (District Court) to set aside the
injunction that was instituted in August 2022 tied to litigation
filed by United Therapeutics (UTHR) alleging patent infringement of
U.S. Patent No. 10,716,793 (the ‘793 Patent) in Case No.
1:20-cv-00755-RGA (the Original Hatch-Waxman Litigation). On
December 20, 2023, the United States Court of Appeals for the
Federal Circuit (CAFC) affirmed the earlier decision by the Patent
Trial and Appeal Board (PTAB), which found all claims of the ‘793
Patent to be unpatentable due to the existence of prior art cited
by Liquidia in inter partes review proceedings.
Additionally, in September 2023, UTHR filed a second complaint
for patent infringement in District Court in Case No.
1:23-cv-00975-RGA (the New Hatch-Waxman Litigation). As of January
22, 2024, the only patent at issue is U.S. Patent No. 11,826,327
(the ‘327 Patent) which issued November 30, 2023. UTHR has
stipulated to the dismissal of the ‘793 Patent from the New
Hatch-Waxman Litigation as a result of the CAFC decision affirming
invalidity of the '793 Patent. The ’327 Patent, the sole remaining
patent at issue in the New Hatch-Waxman Litigation, was not issued
before Liquidia submitted the NDA for YUTREPIA in January 2020 to
treat PAH. Therefore, the Company believes that final FDA approval
for YUTREPIA will not be subject to any statutory 30-month stay
arising from the New Hatch-Waxman Litigation per Section
505(c)(3)(C) of the Federal Food, Drug and Cosmetic Act.
About YUTREPIA™(treprostinil) inhalation
powder
YUTREPIA is an investigational, inhaled dry powder formulation
of treprostinil delivered through a convenient, low-resistance,
palm-sized device. YUTREPIA was designed using Liquidia’s PRINT®
technology, which enables the development of drug particles that
are precise and uniform in size, shape, and composition, and that
are engineered for enhanced deposition in the lung following oral
inhalation. Liquidia has completed INSPIRE, or Investigation of the
Safety and Pharmacology of Dry Powder Inhalation of Treprostinil,
an open-label, multi-center phase 3 clinical study of YUTREPIA in
patients diagnosed with PAH who are naïve to inhaled treprostinil
or who are transitioning from Tyvaso® (nebulized treprostinil).
YUTREPIA is currently being studied in the ASCENT trial, an
Open-Label Prospective Multicenter Study to Evaluate Safety and
Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary
Hypertension, with the objective of informing YUTREPIA’s dosing and
tolerability profile in patients with PH-ILD. YUTREPIA was
previously referred to as LIQ861 in investigational studies.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on
the development and commercialization of products in pulmonary
hypertension and other applications of its PRINT® Technology. The
Company operates through its two wholly owned subsidiaries,
Liquidia Technologies, Inc. (Liquidia Technologies) and Liquidia
PAH, LLC (Liquidia PAH). Liquidia Technologies has developed
YUTREPIA™ (treprostinil) inhalation powder for the treatment of PAH
and PH-ILD. Liquidia Technologies is also developing L606, an
investigational liposomal formulation of treprostinil administered
twice-daily with a short-duration next-generation nebulizer, for
use in North America. Liquidia PAH provides for the
commercialization of pharmaceutical products to treat pulmonary
disease, such as generic Treprostinil Injection. For more
information, please visit www.liquidia.com.
Tyvaso® is a registered trademark of United Therapeutics
Corporation.
Cautionary Statements Regarding Forward-Looking
StatementsThis press release may include forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
other than statements of historical facts, including statements
regarding our future results of operations and financial position,
our strategic and financial initiatives, our business strategy and
plans and our objectives for future operations, are forward-looking
statements. Such forward-looking statements, including statements
regarding clinical trials, clinical studies and other clinical work
(including the funding therefor, anticipated patient enrollment,
safety data, study data, trial outcomes, timing or associated
costs), regulatory applications and related submission contents and
timelines, including the potential for final FDA approval of the
NDA for YUTREPIA, the FDA’s authority to request new or additional
information related thereto and any potential delays of regulatory
approval in connection therewith, the timeline or outcome related
to patent litigation in the U.S. District Court for the District of
Delaware or inter partes review proceedings conducted at the PTAB,
including appeals of decisions in any such proceedings, the
timeline associated with any regulatory stay provisions, the
issuance of patents by the USPTO and our ability to execute on our
strategic or financial initiatives, involve significant risks and
uncertainties and actual results could differ materially from those
expressed or implied herein. The favorable decisions of lower
tribunals are not determinative of the outcome of the appeals of
the decisions. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “would,” and
similar expressions are intended to identify forward-looking
statements. We have based these forward-looking statements largely
on our current expectations and projections about future events and
financial trends that we believe may affect our financial
condition, results of operations, business strategy, short-term and
long-term business operations and objectives and financial needs.
These forward-looking statements are subject to a number of risks
discussed in our filings with the SEC, as well as a number of
uncertainties and assumptions. Moreover, we operate in a very
competitive and rapidly changing environment and our industry has
inherent risks. New risks emerge from time to time. It is not
possible for our management to predict all risks, nor can we assess
the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements we may make. In light of these risks, uncertainties and
assumptions, the future events discussed in this press release may
not occur and actual results could differ materially and adversely
from those anticipated or implied in the forward-looking
statements. Nothing in this press release should be regarded as a
representation by any person that these goals will be achieved, and
we undertake no duty to update our goals or to update or alter any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact Information
Media & Investors:Jason AdairChief Business
Officer919.328.4400jason.adair@liquidia.com
Liquidia (NASDAQ:LQDA)
過去 株価チャート
から 4 2024 まで 5 2024
Liquidia (NASDAQ:LQDA)
過去 株価チャート
から 5 2023 まで 5 2024