Shots:Approval was based on P-III trials, incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara; MAA of SC Tremfya for mod. to sev. UC under EMA’s review based…
Shots:The EC has approved Tremfya to treat mod. to sev. active UC adults with inadequate response, no response or intolerance to SoCs or biologics; CHMP recommendation under EC review for mod. to sev. active Crohn’s disease with decision anticipated later 2025 Approval was based on P-IIb/III (QUASAR) trial assessing Tremfya (IV induction: 200mg Q4W;…
Takeda at UEG Week 2024: Marcelo Freire from Takeda in an Enlightening Conversation with PharmaShots
Shots: Recently, Takeda shared 32-week interim results from the VERDICT study, which evaluated Entyvio (vedolizumab) for the treatment of patients with ulcerative colitis (UC) Entyvio achieved a stringent endpoint of disease clearance, a new concept in UC clinical research, which is a combination of clinical, endoscopic, and histologic remission Today at PharmaShots, we are joined…
Shots: Dr. Lotus Mallbris shares the positive endpoint results of the VIVID-1 P-III study, evaluating the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn’s disease While shedding light on the mechanism of mirkizumab, Lotus highlights that available therapies to treat Crohn’s disease often fail to achieve clinical…

