RedHill Biopharma Ltd. (NASDAQ:RDHL) shares barely budged approaching noon EST Thursday, as the specialty biopharmaceutical company, announced that following a positive pre-MAA meeting it plans to submit a Marketing Authorization Application (MAA) to the U.K. Medicines & Healthcare products Regulatory Agency (MHRA) seeking approval for RHB-102 (Bekinda) for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV) in adults and children over the age of 12.
"This green light for submission from the U.K.'s MHRA is a major milestone towards potential approval and commercialization of RHB-102 in the UK for treating chemotherapy and radiotherapy induced nausea and vomiting. The MHRA pre-MAA scientific advice meeting evaluated the available RHB-102 clinical and pharmacokinetic data generated to date," said CEO Gilead Raday. "Following the positive input from the MHRA pre-MAA review team we aim to complete our submission of for marketing authorization application of RHB-102 to the UK regulatory authorities in the second half of this year."
RHB-102 is a proprietary 24-hr bimodal release, once-daily oral tablet formulation of ondansetron, a 5-HT3 antagonist considered the gold standard in the treatment and prevention of CINV/RINV. Between 70-80% of patients undergoing chemotherapy or radiotherapy will experience nausea and/or vomiting. The global CINV/RINV market is estimated to be worth over $10 billion by 2031, with the U.K. market expected to grow at 6.4% CAGR, accounting for around 20% of the European market.
RDHL shares were static at 21.6 cents
