Konvomep contains 2mg of omeprazole, a proton pump inhibitor, and 84mg of sodium bicarbonate per mL after reconstitution.
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By simplifying the dosing regimen, the Company hopes to improve patient adherence and treatment outcomes.
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.