Reata Pharmaceuticals Inc.’s hopes, as well as those of many people living with Alport syndrome, were dashed Dec. 8 when the FDA’s 13-member Cardiovascular and Renal Drugs Advisory Committee voted unanimously that the available evidence doesn’t show that the benefits of bardoxolone methyl outweighed its risks in treating the rare genetic condition.
Reata Pharmaceuticals Inc. has agreed to pay former partner Abbvie Inc. $330 million plus royalties to reacquire ex-U.S. development, manufacturing and commercialization rights for the Nrf2 activators bardoxolone methyl and omaveloxolone, as well as other next-generation candidates in the class. Rights to certain Asian markets for bardoxolone remain licensed to Kyowa Kirin Co. Ltd.