Chiesi adds US approval for its rare diseases drug Lamzede

Long approved in Europe, family-owned Italian drugmaker Chiesi Farmaceutici has now received marketing authorization for its Lamzede (velmanase alfa-tycv) in the USA.

Its USA-based unit Chiesi Global Rare Diseases announced that the Food and Drug Administration (FDA) has approved Lamzede,for the treatment of non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients. AM is an ultra-rare, progressive lysosomal storage disorder caused by deficiency in the enzyme α-mannosidase.

The drug comes with a label warning about severe hypersensitivity reactions including cyanosis, emesis, urticaria, erythema, facial swelling, pyrexia, and tremor.