Catalyst Pharmaceutical
Partners, Inc. CPRX, a specialty pharmaceutical company focused on
the development and commercialization of novel prescription drugs targeting
rare (orphan) neuromuscular and neurological diseases, today announced that
its investigational product Firdapse™ (amifampridine phosphate) has received
"Breakthrough Therapy Designation" by the U.S. Food and Drug Administration
(FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic
Syndrome (LEMS). Firdapse™ is Catalyst's investigational therapy that is being
evaluated for the treatment of the debilitating symptoms associated with LEMS,
including muscle weakness.
"We are very pleased to have received Breakthrough Therapy Designation for
Firdapse™ and we are excited by the FDA's decision to place our product in a
category that may enable expedited development and review for patients with
LEMS," said Patrick McEnany, President and Chief Executive Officer of
Catalyst. "With no approved or effective symptomatic treatment currently
available for LEMS, Firdapse™ has the potential to be the first-line treatment
option for patients with this rare condition."
Breakthrough Therapy Designation for Firdapse™ was based on clinical data from
several previously published clinical trials of amifampridine (3,4-DAP) in
patients with LEMS. Firdapse™ has the potential to provide significant relief
of the often debilitating symptoms of the disease, including muscle weakness
(e.g. difficulty walking), difficulty swallowing and talking, drooping of
eyelids and facial weakness.
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