Currently, there are no approved or effective symptomatic treatments for LEMS, which is a rare autoimmune disease, which gives Firdapse the potential to be the first-in-line treatment option for patients with this rare condition.
“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 Catalyst President and CEO Patrick McEnany.
Firdapse’s receipt of Breakthrough Therapy Designation was based on clinical data from various previously published clinical trials of amifampridine (3,4-DAP) in LEMS patients. Firdapse can potentially offer great relief for the often debilitating symptoms of LEMS, which include muscle weakness, such as difficulty walking; difficulty swallowing and talking; eyelid drooping; and facial weakness.
Firdapse, which has previously received orphan drug designation, is currently undergoing testing in a global, multicenter, pivotal Phase III trial. In addition to LEMS, Firdapse has other potential orphan neuromuscular indications, including for myasthenia gravis and congenital myasthenic syndrome.
For more information, visit www.catalystpharma.com
About MissionIR
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website
http://www.missionir.com/disclaimer.html
No comments:
Post a Comment