For patients with asthma or COPD, the therapeutic effects of Wixela™ Inhub™ (Mylan, Inc.) are equivalent to Advair® Diskus® (GlaxoSmithKline), according to study results published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery.

Wixela Inhub is a generic equivalent of Advair Diskus (fluticasone propionate [FP]/salmeterol fixed-dose combination).

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The study included patients aged ≥18 years with mild to moderate persistent asthma (n=1127). Patients were randomly assigned to Wixela Inhub (n=512), Advair Diskus (n=512), or placebo (n=103). The researchers used forced expiratory volume in 1 second (FEV1) to compare the local therapeutic equivalence of FP/salmeterol (100/50 μg) after inhaled delivery.


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Patients treated with both Wixela and Diskus had significantly increased day 1 FEV1 area under the effect curve over 12 hours of the change from baseline (AUC[0-12]) compared with placebo. Both Wixela and Diskus also significantly increased day 29 trough FEV1 compared with placebo. This indicated that the study end points sufficiently assessed bioequivalence.

On day 1 of treatment, patients taking Wixela and Diskus increased FEV1 AUC(0–12) compared with placebo (3.134 L/h for Wixela, 2.677 L/h for Diskus; each P <.0001). After twice-daily dosing for 28 days, patients treated with Wixela and Advair had increased trough FEV1 compared with placebo, measured on day 29 (235 mL for Wixela, 215 mL for Diskus; each P <.0001).

The results indicated that the least-squares mean Wixela to Diskus ratios for day 1 FEV1 AUC(0–12) and day 29 trough FEV1 were 1.120 (90% CI, 1.016–1.237) and 1.069 (90% CI, 0.938–1.220), respectively. This indicated that Wixela and Diskus were bioequivalent for both co-primary study end points.

“Wixela Inhub … will represent a new generic-equivalent [FP/salmeterol] treatment option for asthmatic patients whose symptoms are uncontrolled with [inhaled corticosteroids] alone and COPD patients at high risk of exacerbations,” the researchers wrote.

Disclosure: This clinical trial was supported by Mylan, Inc. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Ng D, Kerwin EM, White MV, et al. Clinical bioequivalence of Wixela Inhub and Advair Diskus in adults with asthma [published online October 31, 2019]. J Aerosol Med Pulm Drug Deliv. doi:10.1089/jamp.2019.1547