RedHill Biopharma granted marketing approval in Germany for its Rizaport in migraines

The German regulator has granted marketing approval for Rizaport (RHB-103) from Israeli pharma company RedHill Biopharma to treat acute migraines.

RedHill developed the therapy together with Canadian drug delivery company IntelGenx Corp. The Federal Institute for Drugs and Medical Devices of Germany has granted marketing authorization of Rizaport in 5mg and 10mg formulations in an oral thin film of rizatriptan benzoate to treat acute migraines.

In terms of US approval, the companies submitted a New Drug Application to the Food and Drug Administration seeking marketing approval for Rizaport in 2013. They received a complete response letter from the FDA, raising questions about chemistry and manufacturing controls, but no deficiency was raised relating to safety or bioequivalence data for Rizaport.