After several years of refinement, LEMs
were unveiled in 1998.
Additional status and explanatory data is loaded for requisitions by each responsible LEM
"We are delighted to have received Priority Review status for Firdapse for the treatment of LEMS
and look forward to continuing to work closely with the FDA during the review process," commented Patrick J McEnany, chairman and CEO of Catalyst.
is a rare autoimmune disease with primary symptoms of muscle weakness, fatigue, muscle aches and autonomic dysfunction, such as impotence, dry mouth and constipation.
Previously, the company has received positive results from its first Phase 3 clinical trial evaluating Firdapse (amifampridine phosphate) for the treatment of LEMS
Catalyst has previously received Orphan Drug Designation for Firdapse to treat LEMS
and CMS, and Breakthrough Therapy Designation for Firdapse to treat LEMS
According to the company, its lead candidate, Firdapse for the treatment of LEMS
, has recently completed testing in a global, multi-centre, pivotal Phase 3 trial resulting in positive top-line data.
M2 EQUITYBITES-October 16, 2013-Catalyst Pharmaceutical Partners Inc to continue with Pivotal Phase lll clinical trial of Firdapse to treat LEMS
upon DMC's approval(C)2013 M2 COMMUNICATIONS http://www.m2.com
M2 PHARMA-October 16, 2013-Catalyst Pharmaceutical Partners Inc to continue with Pivotal Phase lll clinical trial of Firdapse to treat LEMS
upon DMC's approval(C)2013 M2 COMMUNICATIONS
6 January 2010 - US-based biopharmaceutical company BioMarin Pharmaceutical Inc (NASDAQ: BMRN) announced yesterday that the European Commission has granted marketing approval for 3,4-diaminopyridine (amifampridine phosphate), for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS
30 November 2009 - US-based BioMarin Pharmaceutical Inc (NASDAQ: BMRN) said today that the US Food and Drug Administration (FDA) has granted Orphan Drug designation for 3,4-diaminopyridine (3,4-DAP), amifampridine phosphate, for Lambert Eaton Myasthenic Syndrome (LEMS