Just ahead of its Nov. 13 PDUFA date, revefenacin won FDA approval, becoming the first once-daily nebulized bronchodilator cleared for chronic obstructive pulmonary disease in the U.S.

Branded Yupelri, the drug, developed by partners Theravance Biopharma Inc. and Mylan NV, is a long-acting muscarinic antagonist (LAMA). It will go up against Sunovion Pharmaceuticals Inc.'s Lonhala Magnair (glycopyrrolate), a twice-daily LAMA product approved late last year.

Dublin-based Theravance and Hertfordshire, U.K.-based Mylan said they expect Yupelri to be available before the end of the year. Pricing was not immediately disclosed.

Approval was based on twin phase III studies, which met their endpoints, demonstrating statistically significant improvements from baseline over placebo in trough forced expiratory volume in one second (FEV1) after 12 weeks of dosing for each of two doses studied. Each trial enrolled a combined total of more than 1,250 patients in the U.S. across a range of disease severity, from moderate to very severe COPD. To enable an assessment of the potential add-on benefit of revefenacin, Theravance allowed for participants to continue use of long-acting beta agonist (LABA) and/or LABA/inhaled corticosteroid treatments – something 38 percent of the studied population did. Patients had to be older than 40 and have a smoking history at least equivalent to smoking a pack of cigarettes every day for at least 10 years. More than a third of the patients enrolled were categorized as "very severe" according to the COPD disease staging system, GOLD, short for the Global Initiative for Chronic Obstructive Lung Disease. (See BioWorld Today, Oct. 21, 2016.)

The improvements in trough FEV1 compared to placebo for the intent-to-treat population across both studies was 118 mL for the 88-mcg dose and 145 mL for the 175-mcg dose.

The companies also completed a 12-month phase III open-label safety study testing Yupelri against tiotropium, with no new safety issues identified. Rates of adverse events and severe adverse events in the study were low and comparable to those seen in the tiotropium treatment arm.

Yupelri is designed to be compatible with any standard jet nebulizer, the companies said.

COPD, which has been cited as the third leading cause of death and the fourth leading cause of hospital readmissions in the U.S., is estimated to affect about 16 million Americans.

Shares of Theravance (NASDAQ:TBPH) closed Friday at $25.81, up $1.26.