Gil Roth12.18.13
Ipsen supplier Lonza has successfully re-manufactured the API of Increlex (mecasermin [rDNA origin] Injection) and Ipsen has informed the EMA that it is preparing for the resupply of Increlex in the EU. Consultations with the EU Member States’ national competent authorities are now in process to allow immediate resupply. Resupply in the U.S. is still pending. Ipsen has been actively managing the shortage period in the U.S. to reduce its impact on patients.
Increlex is used to treat patients with Severe Primary IGF-1 Deficiency (Primary IGFD) and is considered to be a drug of medical necessity. Increlex’s active substance (IGF-1) for the treatment of Severe Primary IGF-1 Deficiency (Primary IGFD), a recombinant insulin-like growth factor of human origin, is manufactured by Lonza Biologics Inc. at its Hopkinton, MA facility.
On April 25 2013, Ipsen announced that Lonza was facing manufacturing issues with Increlex at that site. Lonza has been working closely with the FDA to address these issues. The supply interruption occurred in mid-June 2013 in the U.S. and in 3Q13 in Europe and the rest of the world.
Increlex is used to treat patients with Severe Primary IGF-1 Deficiency (Primary IGFD) and is considered to be a drug of medical necessity. Increlex’s active substance (IGF-1) for the treatment of Severe Primary IGF-1 Deficiency (Primary IGFD), a recombinant insulin-like growth factor of human origin, is manufactured by Lonza Biologics Inc. at its Hopkinton, MA facility.
On April 25 2013, Ipsen announced that Lonza was facing manufacturing issues with Increlex at that site. Lonza has been working closely with the FDA to address these issues. The supply interruption occurred in mid-June 2013 in the U.S. and in 3Q13 in Europe and the rest of the world.