Catalyst Pharmaceuticals Announces FDA Acceptance of the Supplemental New Drug Application for FIRDAPSE®
13 Outubro 2023 - 9:03AM
Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq:
CPRX) today announced that the U.S. Food and Drug
Administration ("FDA" or "Agency") has accepted for review the
Company's supplemental New Drug Application ("sNDA") to increase
the indicated maximum daily dosage of
FIRDAPSE® (amifampridine) Tablets 10 mg from 80mg to 100mg for
the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). The
Agency assigned a Prescription Drug User Fee Act ("PDUFA") action
date of June 4, 2024. FIRDAPSE is currently approved in the U.S.
for the treatment of LEMS for adults and for children ages six to
seventeen.
"We are pleased by the Agency's acceptance of
the sNDA filing for FIRDAPSE, marking yet another milestone in the
advancement of our initiative to address an important need of LEMS
patients and their physicians who desire an increased daily
dosage," stated Patrick J. McEnany, Chairman and CEO of Catalyst.
"FIRDAPSE has proven to be an important therapeutic option for
individuals in the U.S. affected by LEMS, including those comorbid
with small-cell lung cancer. If approved, this will offer
additional indicated dosage options for LEMS patients who may
benefit from a FIRDAPSE daily dosage greater than 80mg and further
underscores our unwavering commitment to the patient communities we
serve. We look forward to working collaboratively with the Agency
during the application review process."
Lambert-Eaton myasthenic syndrome, or LEMS, is a
rare autoimmune neuromuscular disorder characterized primarily by
muscle weakness of the limbs. The disease is caused by an
autoimmune reaction where antibodies are formed against
voltage-gated calcium channels on nerve endings, which damages the
channels. These calcium channels are responsible for the transport
of charged calcium atoms that activate the biochemical machinery
responsible for releasing acetylcholine. Acetylcholine is the
neurotransmitter responsible for causing muscles to contract, and
the failure to release enough of this neurotransmitter results in
muscle weakness in LEMS patients.
Additionally, LEMS is often associated with an
underlying malignancy, most commonly small-cell lung cancer, and in
some individuals, LEMS is the first symptom of such malignancy.
About Catalyst Pharmaceuticals
With exceptional patient focus, Catalyst is
committed to developing and commercializing innovative
first-in-class medicines that address rare neurological and
epileptic diseases. Catalyst's flagship U.S. commercial
product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved
for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") for
adults and for children ages six to seventeen. In January
2023, Catalyst acquired the U.S. commercial rights to
FYCOMPA® (perampanel) CIII, a prescription medicine approved
in people with epilepsy aged four and older alone or with other
medicines to treat partial-onset seizures with or without
secondarily generalized seizures and with other medicines to treat
primary generalized tonic-clonic seizures for people with epilepsy
aged 12 and older. Further, Canada's national healthcare
regulatory agency, Health Canada, has approved the use of
FIRDAPSE for the treatment of adult patients
in Canada with LEMS. Finally, on July 18, 2023,
Catalyst acquired an exclusive license for North
America for vamorolone, a promising best-in-class dissociative
anti-inflammatory steroid treatment for Duchenne Muscular
Dystrophy. Vamorolone has received FDA Orphan Drug and Fast
Track designations and has been granted a PDUFA action date
of October 26, 2023.
For more information about Catalyst
Pharmaceuticals, Inc., visit the Company's website
at www.catalystpharma.com. For Full Prescribing and Safety
Information for FIRDAPSE®, visit www.firdapse.com. For Full
Prescribing Information, including Boxed WARNING for FYCOMPA®,
please visit www.fycompa.com.
Forward-Looking StatementsThis
press release contains forward-looking statements. Forward-looking
statements involve known and unknown risks and uncertainties, which
may cause Catalyst's actual results in future periods to differ
materially from forecasted results. A number of factors, including
(i) whether the sNDA will be approved, and (ii) those factors
described in Catalyst's Annual Report on Form 10-K for the fiscal
year 2022 and its other filings with the U.S. Securities and
Exchange Commission ("SEC"), could adversely affect Catalyst.
Copies of Catalyst's filings with the SEC are available
from the SEC, may be found on Catalyst's website, or may be
obtained upon request from Catalyst. Catalyst does not undertake
any obligation to update the information contained herein, which
speaks only as of this date.
Source: Catalyst Pharmaceuticals, Inc.
Investor Contact
Mary Coleman
Catalyst Pharmaceuticals, Inc.
(305) 420-3200
mcoleman@catalystpharma.com
Media Contact
David Schull
Russo Partners
(858) 717-2310
david.schull@russopartnersllc.co
Catalyst Pharmaceuticals (NASDAQ:CPRX)
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