Partners Theravance and Mylin Submit New Drug Application for Revefenacin as COPD Treatment

The COPD therapy-development partners Theravance Biopharma and Mylan have submitted a New Drug Application for revefenacin (TD-4208) to the U.S. Food and Drug Administration.

Revefenacin is a long-lasting mist. The partners designed it so that chronic obstructive pulmonary disease need to take it only once a day.

The therapy is called a long-acting muscarinic antagonist, or LAMA. It blocks a neurotransmitter called acetylcholine’s ability to bind with muscarinic receptors in airways. The result is a widening of airways, making breathing easier.

The FDA has authorized pill and liquid versions of LAMAs, but never a mist version. A New Drug Application is basically a formal request that the agency approve a therapy. No approval can occur without it.

Under their strategic alliance, Theravance will develop and commercialize revefenacin in the United States, and Mylan outside the U.S.

Nearly 9 percent of COPD patients in the United States use nebulizers, or devices that can generate a mist, as a maintenance therapy, according to market research that Theravance requested.

The partners hope revefenacin becomes a hit with patients who need a LAMA but either require or prefer a mist.

“This submission represents a key step in our efforts to bring the first once-daily nebulized LAMA to the COPD patient community,” Dr. Brett Haumann, Theravance’s chief medical officer, said in a press release. “While a significant number of COPD patients require or prefer nebulized therapy, these same patients currently have no access to a nebulized LAMA, broadly considered the cornerstone of COPD maintenance therapy.

“We are pleased with the comprehensive data package that was generated through our Phase 3 efficacy and safety studies and look forward to the FDA’s review” of the New Drug Application, Haumann added.

The partners used the positive results of two Phase 3 clinical trials (NCT02512510 and NCT02459080) and a Phase 3 safety trial (NCT02518139) to support the application.

The trials showed that revefenacin leads to significant improvements in patients’ COPD symptoms, compared with a placebo. The yardstick researchers used was forced expiratory volume in one second. FEV1 is the amount of air a person can exhale in one second after taking a deep breath.

Both doses of revefenacin tested in the trials — 88 mcg and 175 mcg — were found to be safe. Adverse events were similar between the treated and placebo groups.

“We are proud of our collaboration with Theravance Biopharma over the past two years on the development of revefenacin and the quality of our NDA [New Drug Application] submitted to the FDA,” said Rajiv Malik, Mylan’s  president. “If approved, this product will further strengthen Mylan’s expertise in nebulized respiratory therapies and bolster our commercial presence in the respiratory space.”