Acorda Resubmits New Drug Application for INBRIJA™ (CVT-301, levodopa inhalation powder)
December 07 2017 - 6:00AM
Business Wire
Acorda Therapeutics (Nasdaq:ACOR) announced the resubmission of
its New Drug Application (NDA) for INBRIJA to the U.S. Food and
Drug Administration (FDA). INBRIJA is an investigational treatment
for symptoms of OFF periods in people with Parkinson’s disease
taking a carbidopa/levodopa regimen.
The resubmission addressed the two issues raised in the recent
Refusal to File (RTF) letter and included all additional
information requested by the FDA in that letter.
The INBRIJA NDA is being submitted as a 505(b)(2) application.
FDA is expected to inform Acorda within 74 days if the submission
has been deemed complete and permits a full review.
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 court decision in
our litigation against filers of Abbreviated New Drug Applications
to market generic versions of Ampyra in the U.S.; the risk of
unfavorable results from future studies of Inbrija (CVT-301,
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; 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171207005333/en/
Acorda TherapeuticsFelicia Vonella,
914-326-5146fvonella@acorda.com
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