July 27, 2009
Insmed Inc, today announced that, effective immediately, the Company will cease the supply of Iplex to any new patients. In addition, the Company will not initiate further clinical trials with Iplex at this time. The Company has determined that its limited inventory on hand must be conserved for the treatment of existing patients.
FDA Position on Allowing Patients with ALS Access to Iplex under an IND FDA Summary of Controlled Clinical Data for Human IGF-1 in Treatment of Patients with Amyotrophic Lateral Sclerosis(PDF - 218KB) The IPLEX Experience in Italy(PDF - 29KB) Italian Ministry of Health Paper on Treatment of ALS with Iplex (unofficial English translation)(PDF - 56KB) Agenzia Italiana del Farmaco Paper on Treatment of ALS with Iplex (unofficial English translation)(PDF - 60KB)