IntelGenx Technologies Corp. (OTCMKTS:IGXT) and RedHill Biopharma Ltd – ADR (NASDAQ:RDHL) have submitted a “MAA” that is Marketing Authorization Application to the German Federal Institute for Drugs and Medical Devices. The two companies have developed RIZAPORT® for the treatment of acute migraines. They have submitted an application to get the European marketing approval for RIZAPORT.
The FDA conditionally approved the brand name RIZAPORT® as per the new drug application review process in the US. The companies received a complete response letter on the matter from the FDA in February 2014. The CRL raised questions pertaining to Chemistry, Manufacturing and Controls. The FDA approval in the US is subject to the satisfactory solution of the raised CMC questions. It also needs to get a compliant means of the raw material. As of now, the discussions are on with the FDA to resolve the raised CMC questions. Therefore, the Marketing Authorization Application is submitted as per the Mutual Recognition Procedure in Europe. Germany will be the reference member state in the procedure.
The “MAA” is supported by several clinical studies. It includes the latest comparative study in which European reference drug, Maxalt® Lingua and RIZAPORT® were compared. The study revealed the bioequivalence between the two drugs. Following the results, it can result in a scientific advice meeting to be held with the BfArM. RIZAPORT® is an oral thin film formulation in which patient doesn’t have to swallow a pill. It is an innovative therapeutic medication for migraine patients. It is especially meant for the patients who show migraine-related nausea. It is significant as such patient forms 80% of the total number. The submission of application in Europe brings the company closer to its objective of offering RIZAPORT® to the migraine patients suffering from nausea and vomiting. The management is optimistic on getting a nod for Marketing Authorization Application in Europe.