Mylan Inc., one of the world's leading global pharmaceutical companies, has initiated phase III clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus.
In October 2014, Mylan will commence a phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
Two phase III clinical trials for Mylan's insulin analog programme already are underway. In August 2014, the company initiated INSTRIDE 1 and INSTRIDE 2 to compare the efficacy and safety of Mylan's insulin Glargine with that of Lantus in both type 1 and type 2 diabetes mellitus patients.
Mylan CEO Heather Bresch said, "The commencement of phase III clinical trials for Mylan's generic Advair Diskus and insulin Glargine programmes are important milestones in the progress of two of our strategic growth drivers, demonstrating our strong capabilities in developing complex, difficult-to-manufacture products. We look forward to providing patients with access to high quality, more affordable versions of these medications upon final FDA approval."
Mylan president Rajiv Malik added, "These noteworthy clinical trial developments, combined with the significant strides we have made in advancing our production scale manufacturing, 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. These products, in addition to the hundreds of others in our pipeline, will continue to expand and diversify our portfolio and further differentiate Mylan with its customers."
The clinical trial is a randomized, double-blind, double dummy, parallel group study to determine the local equivalence of multiple doses of Mylan's generic product to Advair Diskus when administered via oral inhalation in adult asthma patients. The primary endpoint of the study is the FEV1 area under the effect curve, which is the volume of air that has been forcibly exhaled in one second, after full inspiration. The study also will examine adverse events and device usability. The study is expected to commence in October 2014 and be completed in April 2015.
INSTRIDE 1 and INSTRIDE 2 are open-label, randomized, multicenter, parallel-group clinical trials comparing the efficacy and safety of Mylan's insulin Glargine with that of Lantus in type 1 and type 2 diabetes mellitus patients, respectively. The purpose of both studies is to test whether Mylan's insulin Glargine once daily is non-inferior to Lantus once daily when administered in combination with other anti-diabetic drugs. Both studies commenced in August 2014 and are expected to be completed in June 2016.