EMA Approves Two Hybrid Medicines

A marketing authorization should be given for orphan medicine Agilus (dantrolene sodium, hemiheptahydrate) for the treatment of malignant hyperthermia, the European Medicines Agency (EMA) has said.

Malignant hyperthermia is a rare disorder in which skeletal muscles are overstimulated and unable to relax. Sudden onset can be triggered by volatile anesthetics and the muscle relaxant succinylcholine, or occasionally by stresses such as vigorous exercise or heat. Malignant hyperthermia can be life-threatening because it causes a rapid rise in body temperature and/or metabolic acidosis.

Agilus is a hybrid medicine of muscle relaxant dantrolene sodium (Dantrolen IV 20 mg), which has been authorized in the European Union since 1984. It works by binding to the ryanodine receptor 1, preventing release of calcium from the sarcoplasmic reticulum.

The Committee for Medicinal Products for Human Use (CHMP) said studies had demonstrated that Agilus is of satisfactory quality and bioequivalence compared with the reference product Dantrolen IV 20 mg.

Source: MEDspace