Insmed of the USA has been requested by the Italian Ministry of Health, to make its drug, Iplex (rhIGFI/rhIGFBP-3), available to physicians in Italy to treat patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease.
The request comes as a result of several Italian Court rulings ordering the Italian National Health System to provide the drug to specific ALS patients who have petitioned the Court. Through an agreement with Cephalon, which holds European patent rights to IGF-1 in the treatment of ALS, Insmed will be able to provide Iplex to physicians in Italy. It will be distributed through an expanded access program, with Insmed receiving payment for the drug from the Italian health authorities.
In Italy, there are an estimated 1,000 new cases of ALS each year and the Ministry has tried for several years to provide IGF, which is approved in the USA, for these patients and, in doing so, has contacted several drugmakers worldwide, according to Insmed.
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