Duexis ibuprofen/famotidine regulatory update

Horizon said the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) approved Duexis ibuprofen/famotidine to treat osteoarthritis (OA), rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing NSAID-associated gastric and/or duodenal ulcers. Horizon said it plans to seek 1 or more commercialization partners for Duexis in Europe. The MAA for Duexis was being reviewed under the EU Mutual Recognition Procedure, with the U.K. acting as the reference member state. In December, Horizon said the MHRA recommended approval of the product (see BioCentury, Jan. 7). ...