Catalyst Pharmaceuticals Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE®
May 30 2024 - 1:41PM
Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company")
(Nasdaq: CPRX), a commercial-stage biopharmaceutical company
focused on in-licensing, developing, and commercializing novel
medicines for patients living with rare and difficult-to-treat
diseases, today announced that the U.S. Food and Drug
Administration (“FDA”) has approved its supplemental New Drug
Application (“sNDA”) increasing the indicated maximum daily dose of
FIRDAPSE® (amifampridine) for adults and pediatric patients
weighing more than 45 kg from 80 mg to 100 mg for the treatment of
Lambert-Eaton myasthenic syndrome (“LEMS”). The increased maximum
daily dose offers healthcare providers and patients greater
flexibility in treatment regimens for the management of LEMS.
LEMS is a rare autoimmune disorder characterized
by muscle weakness and fatigue. FIRDAPSE is a potassium channel
blocker indicated for the treatment of LEMS in adults and pediatric
patients six years of age and older and works by increasing the
release of acetylcholine, a neurotransmitter, at the neuromuscular
junction, which helps improve muscle function in people with LEMS.
FIRDAPSE is currently the only U.S. approved treatment for LEMS and
this approval broadens the approved dosing options for prescribers
treating LEMS.
“We are pleased to receive the approval for the
increased maximum daily dose of FIRDAPSE,” said Richard J. Daly,
President and CEO of Catalyst. “This pivotal achievement further
underscores our dedication to meeting the evolving needs of LEMS
patients and their healthcare providers. We believe that this
milestone will have a meaningful impact on the lives of LEMS
patients, offering a new level of flexibility in treatment while
aligning with our overarching mission to optimize LEMS patient
outcomes.”
Patients in the U.S. can access FIRDAPSE by
prescription through their healthcare providers. For those seeking
more information, the Catalyst Pathways® Patient Assistance Program
for FIRDAPSE® offers comprehensive support, including a dedicated
team to assist families throughout the treatment journey for
eligible patients. Caregivers and healthcare professionals may call
1-833-422-8259 or visit www.yourcatalystpathways.com for further
details.
For additional information, please visit the
company website at Catalyst Pharmaceuticals.
About Catalyst Pharmaceuticals,
Inc.With exceptional patient focus, Catalyst is committed
to developing and commercializing innovative first-in-class
medicines that address rare and difficult-to-treat 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.
On July 18, 2023, Catalyst acquired an exclusive license
for North America for AGAMREE® (vamorolone) oral
suspension 40 mg/mL, a novel corticosteroid treatment for Duchenne
Muscular Dystrophy. AGAMREE previously received FDA Orphan Drug and
Fast Track designations and was approved by the FDA for
commercialization in the U.S. on October 26, 2023.
AGAMREE became commercially available by prescription in
the U.S. on March 13, 2024.
For more information about Catalyst
Pharmaceuticals, Inc., please visit the Company's website
at www.catalystpharma.com. For Full Prescribing and Safety
Information for FIRDAPSE®, please visit www.firdapse.com. For
Full Prescribing Information, including Boxed WARNING for FYCOMPA®,
please visit www.fycompa.com. For Full Prescribing Information
for AGAMREE®, please visit www.agamree.com.
Forward-Looking Statements This
press release contains forward-looking statements, as that term is
defined in the Private Securities Litigation Reform Act of 1995.
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 those factors described in Catalyst's Annual
Report on Form 10-K for the fiscal year 2023 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.com
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