Liquidia Resubmits New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial H...
May 10 2021 - 6:30AM
Liquidia Corporation (NASDAQ: LQDA) announced today that on May 7,
2021, it resubmitted its New Drug Application (NDA) for LIQ861 for
the treatment of pulmonary arterial hypertension (PAH). The U.S.
Food and Drug Administration (FDA) issued a Complete Response
Letter (CRL) regarding the NDA in November 2020 indicating that the
application was incomplete and not ready for approval in its
present form. Liquidia and the FDA held a Type A meeting in January
2021 to discuss the CRL and the requirements for the NDA
resubmission.
The resubmitted NDA includes additional information
and clarification on chemistry, manufacturing, and controls (CMC)
pertaining to the drug product as well as data on device
biocompatibility. No additional data from clinical trials or
studies related to toxicology or clinical pharmacology was
required. The Company anticipates that the FDA will classify the
resubmitted NDA, if accepted, as a Class 2 Resubmission, which
would result in a six-month review cycle from the date of
resubmission.
In addition to the items identified in the CRL, the
FDA also confirmed the need to conduct on-site pre-approval
inspections. The FDA noted it had been unable to conduct these
inspections in 2020 during the initial review cycle due to COVID-19
related travel restrictions. The company remains prepared to
conduct these inspections at any time.
Damian deGoa, Chief Executive Officer of Liquidia,
said: “The team has worked hard to provide a comprehensive and
rapid response to the CRL. We look forward to working with the FDA
through the review process during the coming
months.”
About Liquidia
CorporationLiquidia 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. and Liquidia PAH,
LLC. Liquidia Technologies is developing LIQ861, an inhaled dry
powder formulation of treprostinil for the treatment of PAH.
Liquidia PAH provides the commercialization for rare disease
pharmaceutical products, such as Treprostinil Injection. For more
information, please visit www.liquidia.com.
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 our response to the Complete Response Letter received in
November 2020, the potential for eventual FDA approval of
the NDA for LIQ861, the timeline or outcome related to our patent
litigation pending in the U.S. District Court for the District
of Delaware or our inter partes review with the
PTAB, 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 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, including the risk that the expected benefits and
synergies from the Merger Transaction are not realized, the impact
of the coronavirus (COVID-19) outbreak on our Company and our
financial condition and results of operations, 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
InformationInvestors & Media:Jason
AdairVice President, Corporate Development and
Strategy919.328.4400jason.adair@liquidia.com
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