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news.The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated Israeli biopharmaceutical firm RedHill Biopharma's marketing authorization application (MAA) for Bekinda indicated for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV), respectively.
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Bekinda (RHB-102) is a proprietary once-daily oral pill formulation of the antiemetic drug ondansetron.
The UK MHRA has started the formal review process for the MAA on 30 December 2014 and the company expects to receive feedback for the application during the second half of 2015.
With Bekinda, the company is targeting a considerable segment of the 5-HT3 oncology support antiemetic market.
The submission of the application followed a positive European Scientific Advice meeting with the UK MHRA and is based on several pharmacokinetic trials which support the safety and efficacy of Bekinda for prevention of nausea and vomiting following chemotherapy and radiotherapy treatments.
RedHill CEO Dror Ben-Asher said: "The acceptance for review of the Bekinda(TM) MAA, our third marketing application filed to date, positions us to receive regulatory feedback for Bekinda in the second half of 2015.
"We are entering 2015 with three ongoing Phase III studies in our core therapeutic area of gastrointestinal diseases, and we expect to have top-line results from two of these studies, with RHB-105 for H. pylori infection and Bekinda for gastroenteritis, in the second quarter and second half of 2015, respectively."
The Israeli company is also pursuing marketing approval of Bekinda in the US.
In order to further support the planned submission of a US new drug application (NDA) for Bekinda to prevent chemotherapy induced nausea and vomiting, the company plans to use post-marketing data from Europe, along with the data generated from prior studies.