New indication approved for Recordati's Carbaglu in USA

Recordati (RECI: MI) has announced that the US Food and Drug Administration (FDA) has approved a new indication for Carbaglu (carglumic acid) tablets 200mg.

The 200mg tablets have been approved as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) in pediatric and adult patients.

Carbaglu was initially approved by the FDA for N-acetylglutamate synthase (NAGS) deficiency, another rare metabolic disorder, as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency, and maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.