New PDUFA Date of January 5, 2019
ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR) 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 INBRIJA™ (levodopa inhalation powder) from October
5, 2018 to January 5, 2019.
This extension is related to recent submissions Acorda made in response
to requests from FDA for additional information on chemistry,
manufacturing and controls (CMC). FDA determined that these submissions
constitute a major amendment and will take additional time to review.
“We look forward to continuing our constructive dialogue with FDA,” said
Ron Cohen, M.D., Acorda’s President and CEO. “We remain committed to
bringing INBRIJA to approval for people with Parkinson’s who experience
OFF periods, which are highly disruptive and in need of new therapeutic
options.”
The FDA accepted Acorda’s NDA for INBRIJA in February 2018.
About Parkinson’s and OFF periods
Parkinson’s is a progressive neurodegenerative disorder resulting from
the gradual loss of certain neurons responsible for producing dopamine.
Approximately one million people in the U.S. and 1.2 million Europeans
are diagnosed with Parkinson’s; it is estimated that approximately 40
percent of people with Parkinson’s experience OFF periods. It causes a
range of symptoms including impaired movement, muscle stiffness and
tremors. As Parkinson’s progresses, people will experience OFF periods,
which are characterized by the re-emergence of Parkinson’s motor and
non-motor symptoms. This re-emergence can occur even when an
individual’s treatment regimen has been optimized.
About INBRIJA™ (levodopa inhalation powder) and ARCUS®
INBRIJA is a self-administered, orally inhaled levodopa (L-dopa) therapy
in development for the treatment of symptoms of OFF periods in people
with Parkinson’s disease taking a carbidopa/levodopa regimen.
INBRIJA utilizes Acorda’s investigational ARCUS® platform for inhaled
therapeutics. INBRIJA was designed to deliver a precise dose of a dry
powder formulation of L-dopa through the lung. Oral medication can be
associated with variable onset of action, as the medicine is absorbed
through the gastrointestinal (digestive) tract before reaching the
brain. Inhaled treatments enter the body through the lungs and reach the
brain, bypassing the digestive system.
The proprietary name INBRIJA has been conditionally accepted by the U.S.
Food and Drug Administration (FDA).
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biopharmaceutical company
focused on developing therapies that restore function and improve the
lives of people with neurological disorders. Acorda has a pipeline of
novel neurological therapies addressing a range of disorders, including
Parkinson’s disease and multiple sclerosis. Acorda markets two
FDA-approved therapies, including AMPYRA® (dalfampridine) Extended
Release Tablets, 10 mg.
Forward-Looking Statement
This press release includes forward-looking statements. All statements,
other than statements of historical facts, regarding management's
expectations, beliefs, goals, plans or prospects should be considered
forward-looking. These statements are subject to risks and uncertainties
that could cause actual results to differ materially, including: the
ability to realize the benefits anticipated from acquisitions, among
other reasons because acquired development programs are generally
subject to all the risks inherent in the drug development process and
our knowledge of the risks specifically relevant to acquired programs
generally improves over time; we may need to raise additional funds to
finance our operations and may not be able to do so on acceptable terms;
our ability to successfully market and sell Ampyra (dalfampridine)
Extended Release Tablets, 10 mg in the U.S., which will likely be
materially adversely affected by the March 2017 trial court decision in
our litigation against filers of Abbreviated New Drug Applications to
market generic versions of Ampyra in the U.S., which was affirmed by the
appellate court in September 2018; the risk of unfavorable results from
future studies of Inbrija (levodopa inhalation powder) or from our other
research and development programs, or any other acquired or in-licensed
programs; we may not be able to complete development of, obtain
regulatory approval for, or successfully market Inbrija or any other
products under development; risks associated with complex, regulated
manufacturing processes for pharmaceuticals, which could affect whether
we have sufficient commercial supply of Inbrija to meet market demand,
if it receives regulatory approval; third party payers (including
governmental agencies) may not reimburse for the use of Ampyra, Inbrija
or our other products at acceptable rates or at all and may impose
restrictive prior authorization requirements that limit or block
prescriptions; the occurrence of adverse safety events with our
products; the outcome (by judgment or settlement) and costs of legal,
administrative or regulatory proceedings, investigations or inspections,
including, without limitation, collective, representative or class
action litigation; competition; failure to protect our intellectual
property, to defend against the intellectual property claims of others
or to obtain third party intellectual property licenses needed for the
commercialization of our products; and failure to comply with regulatory
requirements could result in adverse action by regulatory agencies.
These and other risks are described in greater detail in our filings
with the Securities and Exchange Commission. We may not actually achieve
the goals or plans described in our forward-looking statements, and
investors should not place undue reliance on these statements.
Forward-looking statements made in this press release are made only as
of the date hereof, and we disclaim any intent or obligation to update
any forward-looking statements as a result of developments occurring
after the date of this press release.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20180913005284/en/
Acorda Therapeutics, Inc.
Media:
Tierney Saccavino,
917-783-0251
tsaccavino@acorda.com
or
Investors:
Felicia
Vonella, 914-326-5146
fvonella@acorda.com
Source: Acorda Therapeutics, Inc.