Recordati receives FDA approval for Carbaglu

Recordati has been granted Food and Drug Administration (FDA) approval for Carbaglu, its treatment for hyperammonaemia caused by NAGS deficiency.

The treatment is designated for both acute and chronic NAGS deficiency-induced hyperammonaemia and is the only specific treatment available to cater for this condition.

NAGS deficiency is an extremely rare condition caused by a lack of the hepatic enzyme N-acetylglutamate synthase, which leads to irreversible damage to the brain and central nervous system.

The company states that its drug will help to prevent this degeneration if the treatment is commenced early, allowing patients to enjoy a relatively high quality of life.

Giovanni Recordati, chairman and chief executive officer of Recordati, said: “We are very pleased with the FDA’s timely decision to approve Carbaglu ? This also represents a significant step in the development of our business dedicated to the treatment of rare and orphan diseases.”

Earlier this month, the company published its financial results for 2009, reporting revenue growth of 8.4 per cent on a year-on-year basis.