EU approves Rinvoq for active ulcerative colitis
AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent
The EC approval is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance. Statistical significance was achieved for the primary endpoint and all secondary endpoints with Rinvoq 45 mg in the two induction studies and both Rinvoq 15 mg and 30 mg in the maintenance study.
During the U-ACHIEVE and U-ACCOMPLISH induction trials, 26 percent and 33 percent of patients treated with Rinvoq 45 mg achieved clinical remission at week 8, the primary endpoint, compared to 5 percent and 4 percent of patients who received placebo. During the U-ACHIEVE maintenance trial, 42 percent and 52 percent of patients treated with Rinvoq 15 mg or 30 mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 percent of patients who received placebo.
Additionally, 57 percent and 68 percent of patients receiving Rinvoq 15 mg or 30 mg, respectively, achieved corticosteroid-free remission, defined as clinical remission (per Adapted Mayo Score) and corticosteroid free for at least 90 days immediately preceding week 52 among patients who achieved clinical remission at the end of the induction treatment, compared to 22 percent of patients on placebo.
Related news and insights
Roche announced that the FDA has approved a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a FDA-approved test, and who have received a prior systemic therapy
The Menarini Group announced that the FDA has accepted the Company’s New Drug Application (NDA) for elacestrant, an investigational selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer.