Advanced Accelerator Applications Receives Positive CHMP Opinion for LysaKare

Advanced Accelerator Applications Receives Positive CHMP Opinion for LysaKare for Reduction of Kidney Exposure to Radiation During Peptide Receptor Radionuclide Therapy with Lutetium (¹⁷⁷Lu) Oxodotreotide (Lutathera ). Saint-Genis-Pouilly, France, June 5, 2019 - Advanced Accelerator Applications S.A. (AAA), a Novartis company, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of LysaKare 25g/25g (arginine hydrochloride/lysine hydrochloride) solution for reduction of renal (kidney) radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (¹⁷⁷Lu) oxodotreotide (Lutathera ) in adults. If approved by the European Commission, LysaKare would be the first commercially registered arginine hydrochloride/lysine hydrochloride amino acid solution of this concentration available in Europe. Lutathera, indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults, was the first PRRT ever approved by the European Commission in September 2017. Lutathera PRRT includes a targeting molecule attached to a radioactive component. The kidneys are the primary dose limiting organs for PRRT with Lutathera, and a lysine and arginine amino acid solution is co-administered to patients to reduce renal uptake and retention of Lutathera, thus reducing renal radiation exposure by approximately 50% and mitigating the risk for radiation-induced renal injury.