September 17, 2014
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Mylan to test generic version of Advair Diskus for asthma treatment

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Mylan will conduct a phase 3 clinical trial to evaluate the equivalence of its generic version of Advair Diskus as inhalation treatment in adults with asthma, according to a press release.

The randomized, double blind, double-dummy, parallel group study will commence in October to determine the local equivalence of Mylan’s generic product to fluticasone propionate and salmeterol inhalation powder (Advair Diskus, GlaxoSmithKline) in adults with asthma, the release said. The study’s primary endpoint is the FEV1 area under the effect curve.

Adverse events and device usability also will be examined. The study is expected to be completed by April.

Heather Bresch

Heather Bresch

Mylan also is conducting two phase 3 trials comparing the efficacy and safety of its insulin glargine to that of Lantus (Sanofi) in patients with type 1 and type 2 diabetes mellitus, the release stated.

“The commencement of phase 3 clinical trials for Mylan’s generic Advair Diskus and insulin glargine programs are important milestones in the progress of two of our strategic growth drivers, demonstrating our strong capabilities in developing complex, difficult-to-manufacture products,” Heather Bresch, Mylan chief executive officer, said in the release. “We look forward to providing patients with access to high-quality, more affordable versions of these medications upon final FDA approval.”

Rajiv Malik

Rajiv Malik

“These noteworthy clinical trial developments … reinforce our continued belief that Mylan will be the first to bring to market an AB-rated, substitutable generic form of Advair Diskus and one of the first to bring to market an interchangeable insulin analog to Lantus,” Rajiv Malik, Mylan president, said in the release.