Konvomep contains 2mg of omeprazole, a proton pump inhibitor, and 84mg of sodium bicarbonate per mL after reconstitution.
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.
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.