Mylan wins US FDA approval for Wixela Inhub for treating asthma & COPD patients
1 February 2019 -

Pharmaceutical company Mylan NV (NASDAQ:MYL) reported on Thursday the receipt of the US Food and Drug Administration's (FDA) approval for Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP) in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg strength for COPD patients.

The company added the Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP) is the first generic version of ADVAIR DISKUS.

In the second half of February, the company will launch Wixela Inhub under the US FDA's latest safety information rules.

According to the company, the Wixela Inhub is indicated for the twice daily treatment of asthma in patients age four and older not adequately controlled on long-term asthma control medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of COPD; and the reduction of COPD exacerbations in patients with a history of exacerbations.

Under the company's 28-day, randomised, double-blind, placebo-controlled, parallel group study of 1,128 adult asthma patients that evaluated the local (lung) bioequivalence of Wixela Inhub 100 mcg/50 mcg and ADVAIR DISKUS 100 mcg/50 mcg, the two treatments produced equivalent efficacy. Both treatments were safe and well-tolerated with lower numbers of withdrawals due to asthma compared to the placebo group. The study included both naive and current users of ADVAIR DISKUS.