Dive Brief:
- Theravance Biopharma Inc. and Mylan N.V. will know the fate of their partnered chronic lung disease drug revefenacin by the end of this year, announcing Monday the Food and Drug Administration had set a target decision date for approval of Nov. 13, 2018.
- If the FDA OK's the drug, revefenacin would become the first once-daily nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD), according to the companies.
- Revefenacin belongs to a class of drugs known as long-acting muscarinic antagonists, or LAMAs, that are frequently used for maintenance treatment of COPD.
Dive Insight:
COPD affects around 30 million people across the U.S. It is incurable and progressive, through managing it can delay its progression. Approaches to its treatment include short- and long-acting bronchodilators, oral corticosteroids to treat or prevent flare-ups and inhalers that combine several types of drugs.
LAMAs like revefenacin, either alone or in combination with long-acting beta-agonists (LABAs), are increasingly used in inhalers to improve lung function.
Recently, companies like GlaxoSmithKline plc and AstraZeneca plc have focused on devleopment of so-called triple inhalers, which pair LAMAs with oral corticosteroids and LABAs. GSK won approval of its Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) in September and clinical results from last week could support an OK for AstraZeneca's own "closed triple" inhaler.
Dry powder or metered dose inhalers aren't always the best option for some people with COPD, who may benefit from nebulizer-based delivery. Mylan and Theravance began collaborating on the drug in early 2015, putting Theravance in charge of development in the U.S.
The filing to the FDA was based on two Phase 3 efficacy studies which showed significant improvements compared to placebo in forced expiratory volume in one second (FEV1) and in overall treatment effect on FEV1 after 12 weeks of dosing. The FDA does not plan to set up an advisory committee meeting to discuss the application, the companies said.
Sunovion Pharmaceutical Inc., a potential rival, had its own nebulized LAMA knocked back by the FDA in May 2017, but finally secured approval of the drug late last year. Called Lonhala Magnair, the drug is expected to launch in early 2018 as the first nebulized LAMA treatment option. Unlike revefenacin, however, Sunovion's drug requires twice-daily dosing (administered in three minutes each time).
While this has pipped Theravance and Mylan to the post, revefenacin could still potentially compete on a potentially more convenient dosing schedule.
Theravance actually benefits from GSK's success with Trelegy as well. In 2014, Theravance Inc. spun off Theravance Biopharma, later changing its name to Innoviva Inc. Under a deal with GSK, Innoviva is entitled to between 6.5% and 10% royalties on global sales of Trelegy — of which Thervance Biopharma receives 85% (or 5.5% to 8.5% of sales).