Mylan Furthers Research On Generic Insulin, Asthma Products
By Lori Clapper
Mylan has announced it will begin Phase 3 clinical trials for its generic version of GlaxoSmithKline's Advair Diskus, following on the heels of the recently launched phase 3 program for its own version of Sanofi's insulin product, Lantus.
Starting in August 2014, Mylan started two Phase 3 clinical trials for its insulin analog program. The INSTRIDE 1 and INSTRIDE 2 studies are open label, randomized, multicenter clinical trials that will compare the efficacy and safety of Mylan's insulin Glargine to that of Lantus in both Type 1 and Type 2 diabetes mellitus patients. Both studies aim to find whether Mylan's once daily insulin product is comparable to Lantus once daily when taken with other anti-diabetic drugs. Both studies are expected to be completed in June 2016.
In October 2014, Mylan plans to begin a randomized, double-blind, double dummy, parallel group, Phase III clinical trial, to assess the equivalence of its generic product to Advair Diskus.
“This study will 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,” according to a company announcement. Researchers will also examine adverse events and device usability. This study should be completed in April 2015.
"The commencement of Phase III 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,” Mylan CEO Heather Bresch said. “We look forward to providing patients with access to high quality, more affordable versions of these medications upon final FDA approval."
Indeed, Mylan President Rajiv Malik says that the company is the first to bring an AB-rated, substitutable generic form of Advair Diskus, as well as one of the first to bring an interchangeable insulin analog of Lantus to market.
More information on the aforementioned clinical trials can be found at clinicaltrials.gov.