French drugmaker Ipsen says that the US Food & Drug Administration has accepted the filing of its New Drug Application for the firm’s product to treat acromegaly.
Somatuline Autogel (lanreotide), already has marketing approval in over 50 countries (including 26 in Europe) for the treatment of acromegaly and neuroendocrine tumours and in six countries for acromegaly alone. It comes as an injectable sustained-release formulation and treats the disorder which is caused by the overproduction of growth hormones secondary to a benign tumour of the anterior pituitary gland.
Ipsen hopes to secure approval in August and if granted, Somatuline Autogel will be marketed by the French firm’s partner Tercica which is currently in the process of rolling out the product in Canada. In October, Ipsen received marketing approval in Europe to sell another new product, febuxostat for the management of symptomatic hyperuricaemia.