Catalyst Pharmaceuticals Advances sNDA Submission Plans To Increase Indicated Maximum Dose For FIRDAPSE® From 80 mg Per Day To 100 mg Per Day
09 Maio 2023 - 9:03AM
Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a
commercial-stage biopharmaceutical company focused on in-licensing,
developing, and commercializing novel high-quality medicines for
patients living with rare diseases, today reported that it recently
concluded a Type C meeting with the U.S. Food and Drug
Administration ("FDA" or "Agency") regarding its plans to file a
supplemental New Drug Application ("sNDA") to increase the maximum
daily dosage of FIRDAPSE® (amifampridine) from 80mg to 100mg for
the treatment of Lambert Eaton myasthenic syndrome ("LEMS"). Based
on the feedback received from the meeting, Catalyst believes it now
has the information necessary to complete the submission of its
sNDA for marketing approval in the U.S. early in the third quarter
of 2023.
"The meeting was held for alignment of our
strategy to support a proposed maximum 100-milligram daily dose
indication of FIRDAPSE," said Patrick J. McEnany, Chairman and
Chief Executive Officer of Catalyst. "We thank the Agency for their
collaboration in reviewing our submitted materials and providing
their feedback. Based on the positive outcome of the meeting, we
remain on track to file an sNDA submission early in the third
quarter of 2023. If approved, we believe this change will address
an important need for LEMS patients, caregivers, and physicians who
may benefit from an optimized therapy."
FIRDAPSE® (amifampridine) Tablets 10mg is currently
approved in the U.S. for the treatment of LEMS in adults and for
children ages six to seventeen with an indicated maximum daily dose
of 80 milligrams.
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 ("SCLC"), 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.
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
Statements This 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
Catalyst can submit an sNDA to increase the indicated maximum dose
of FIRDAPSE® from 80 mg per day to 100 mg per day, and the timing
of that submission, (ii) whether any such sNDA submission will be
accepted for filing by the FDA, (iii) whether any sNDA accepted for
filing will be approved, and the timing of any such approval, and
(iv) 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
Catalyst Pharmaceuticals (NASDAQ:CPRX)
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