The approval was based on data from the phase 1 ELEVATE-PLUS trials, which showed the acalabrutinib 100mg tablets were bioequivalent to the acalabrutinib 100mg capsules.
DDW 2022, News
A team of investigators evaluated the effects of concomitant use of PPIs and advanced therapy on health care resources in patients with IBD.
The approval was based on efficacy and safety data from a phase 3 trial, which included two 24-week treatment periods in patients 12 years of age and older with EoE.
Drugs in the Pipeline
The application is supported by data from the pivotal phase 3 PHALCON-EE trial which compared the efficacy and safety of vonoprazan to lansoprazole in patients with erosive esophagitis.
Increased incidence of CAP was noted in stroke patients using PPIs.
Study is the largest to explore this potential safety issue to date.