Ipsen Works With FDA to Resupply Increlex® in the U.S.
Ipsen today announced that a supply of Increlex® will be available in the U.S. starting June 2, 2014. In collaboration with the FDA, Ipsen is releasing one batch of Increlex ® ’s active ingredient. Ipsen anticipates that additional lots will be released in the coming months, as the company continues to work closely with the FDA to make additional Increlex ® lots available as soon as possible.
Increlex ® is used to treat children with a form of growth failure called severe primary IGF-1 deficiency (IGFD), which can cause permanent short stature. The supply interruption of Increlex ® occurred in mid-June 2013.
“We are very pleased that the resupply of Increlex®will be taking place in the US, as we have been working in very close collaboration with the FDA and the manufacturer Lonza to make this happen,” said Marc De Garidel, Chairman and Chief Executive Officer of Ipsen. He added: “While the manufacturing of a product like Increlex®remains challenging, Ipsen is committed to the children across the world who need this treatment.”