Mylan and Theravance Will Receive FDA Decision on COPD Drug by November

If approved, Revefenacin would be the first once-daily nebulized bronchodilator for the treatment of COPD.

 Recently, triple inhalers that combined three different active ingredients have received significant attention for their ability to treat patients with chronic obstructive pulmonary disease (COPD). GSK won US Food and Drug Administration (FDA) approval for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) in September of 2017 and promising clinical results for AstraZeneca’s version - PT010 inhaler ((budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6µg, using Aerosphere Delivery Technology, in a pressurized metered-dose inhaler or pMDI) – suggest it might become a competitor in the future.

Finding effective drugs for managing COPD is important as this incurable and progressive disease affects approximately 30 million people in the US alone. In addition to the new triple inhalers, other approaches include short- and long-acting bronchodilators and oral corticosteroids to treat or prevent flare-ups.

While very promising, the triple inhalers (dry powder or metered dose) aren’t suitable for everyone. Some people with COPD may benefit from nebulizer delivery. To address this unmet need, Theravance Biopharma Inc. and Mylan N.V. are collaborating on the development of, Revefenacin a long-acting muscarinic antagonist (LAMAs) formulated for nebulizer-based delivery.  

The two companies filed a new drug application with FDA based on the results of two Phase 3 trials. Improvements were observed compared to placebo in forced expiratory volume in one second (FEV1) and in overall treatment effect on FEV1 after 12 weeks of dosing. FDA has set a target decision date for approval of Nov. 13, 2018.

If approved, Revefenacin would become the first once-daily nebulized bronchodilator for the treatment of COPD. It will compete with Sunovion Pharmaceutical’s nebulized LAMA, which received FDA approval in May 2017 and is slated for commercial launch in early 2018. Lonhala Magnair, however, requires twice-daily and is administered for three minutes during each dosing period.


Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.