Advanced Accelerator Applications S.A. (AAA), a Novartis company, 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.
“LysaKare was developed to enhance patient safety and comfort during PRRT with Lutathera,” noted Germo Gericke, M.D., Head of Research and Development for Advanced Accelerator Applications. “This positive opinion by the CHMP supports our commitment to providing the best and most comprehensive care possible.”
Clinical efficacy and safety for arginine and lysine are based on published literature of studies using solutions with the same arginine and lysine content as LysaKare. There are limited data on the safety profile of arginine and lysine solution for infusion without concomitant administration of PRRT, which also includes the use of anti-emetics as pre-medication and often the concomitant use of short acting somatostatin analogues. The main adverse reactions which are related mainly to the amino acid solution are nausea (approximately 25%), vomiting (approximately 10%) and hyperkalaemia. These adverse reactions are mostly mild to moderate.
The European Commission (EC) takes binding decisions on the authorization of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved by the EC, the centralized marketing authorization will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions based on the EC’s recommendation.
The European Commission will review the CHMP opinion and is expected to deliver its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein.