Insmed announced that, effective immediately, it will cease the supply of Iplex (recombinant human insulin-like growth factor-I [rhIGF-I] and IGFBP-3 [rhIGFBP-3] complex), to any new patients. In addition, Insmed will not initiate further clinical trials with Iplex at this time. Insmed no longer has the capability to manufacture Iplex and has determined that its limited inventory on hand must be conserved for the treatment of existing patients. Insmed believes it has sufficient Iplex inventory to supply existing patients for no more than 24 months.
Insmed intends to analyze the on-going data collected for various indications, including myotonic muscular dystrophy and amyotrophic lateral sclerosis (ALS), and assess the overall Iplex development program, including possible Iplex manufacturing options with third parties and possible future clinical trials. Initiation of the Phase 2 Iplex clinical trial for ALS patients in the U.S. that had been discussed with FDA earlier this year has been postponed while this assessment is performed.
For more information call (804) 565-3000 or visit www.insmed.com.