RedHill Reports Acceptance For Review Of BEKINDA European Marketing Application

(RTTNews) - RedHill Biopharma Ltd. (RDHL), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, announced that the UK Medicines and Healthcare Products Regulatory Agency or MHRA has validated the Marketing Authorization Application or MAA for BEKINDA (RHB-102), a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron indicated for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting, and initiated the formal review process for the application on December 30, 2014.

RedHill hopes to receive feedback from the MHRA regarding the MAA in the second half of 2015.

The MAA was submitted to several member states under the European Decentralized Procedure, with the UK as the Reference Member State. The MAA submission followed a positive European Scientific Advice meeting with the UK MHRA and is backed by several pharmacokinetic studies which support the safety and efficacy of BEKINDA for prevention of nausea and vomiting post chemotherapy and radiotherapy treatments.