Theravance Biopharma and Mylan are now on the course to file the NDA in the fourth quarter after successfully obtaining safety data from the two short phase 3 trials of their COPD therapy.
The trial suggests the drug candidate, Revefenacin, has a tolerable safety profile, the trail involved the enrolment of 1,055 COPD patients and then randomizing them to receive one of two doses of the experimental, nebulized long-acting muscarinic antagonist (LAMA) or Spiriva. The participants took revefenacin once a day for a year, at the end of which Theravance and Mylan compared the safety of their candidate to that of Spiriva.
The two arms of the trial featured low rates of adverse events such as exacerbations, nasopharyngitis, upper respiratory tract infections and cough.
The Irish biotech said the rate of COPD exacerbations was lowest in one of the revefenacin arms. Revefenacin also had numerically—but not statistically—fewer reports of dry mouth, constipation and other antimuscarinic side effects.
Regulatory success would mark the end of a development program that has had its ups and downs. GSK, which had, in 2004 picked up the rights to revefenacin, dropped the drug four years later after learning that the formulation was incompatible with its proprietary
inhaler.Theravance later bounced back by repositioning revefenacin as a nebulized product. And, after posting phase 2 data, it landed a backloaded $265 million deal with Mylan in 2015.
