EQUIVALENCE

Demonstrated local bioequivalence to ADVAIR DISKUS® in a clinical endpoint study4

The first therapeutically equivalent generic for ADVAIR DISKUS, WIXELA INHUB is the result of a rigorous 10-year research and development program.2,5

In addition to demonstrating WIXELA INHUB bioequivalence to ADVAIR DISKUS via in-vitro and pharmacokinetic studies, Viatris conducted a clinical endpoint study to show the local (lung) bioequivalence of WIXELA INHUB 100/50 and ADVAIR DISKUS 100/50. Both WIXELA INHUB 100/50 and ADVAIR DISKUS 100/50 showed statistically significant efficacy versus placebo (p<0.0001) on FEV1 AUEC0-12 hrs on Day 1 and trough FEV1 on Day 29.4

Evaluation of salmeterol component by FEV1 AUEC0-12 hrs on Day 1 and fluticasone propionate component by trough FEV1 on Day 294

Graph showing the change from baseline (mean and 95% CI) in FEV1 (L) over time of day on Day 1 and at Day 29 between Wixela, Advair and placebo

Proven equivalence to ADVAIR DISKUS 100/50 for both salmeterol and fluticasone propionate components

Graph showing plot of bioequivalence test LS means ratio and 90% CI for FEV1 AUEC 0-12 (L.HR) change from baseline on day 1 (visit 3) and change from baseline in trough FEV1 (L) on day 29 (+-2 days; visit 5)

As an FDA-approved therapeutically equivalent generic, WIXELA INHUB can be expected to have the same safety profile as ADVAIR DISKUS