The FDA raised the bar in long-term treatment of chronic obstructive pulmonary disease (COPD) with the approval of combination product Anoro Ellipta. Developed by Glaxosmithkline plc (GSK) and partner Theravance Inc., Anoro (vilanterol plus umeclidinium bromide), delivered by inhaler, pairs a long-acting muscarinic antagonist (LAMA) with a long-acting beta2 agonist (LABA).

Although vilanterol was approved in combination with fluticasone furoate as GSK’s Breo (fluticasone furoate /vilanterol) Ellipta – also for COPD in partnership with Theravance – Anoro Ellipta becomes the first once-daily product approved in the U.S. that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The FDA-approved strength is umeclidinium/vilanterol 62.5 mcg/25 mcg. Anoro is not indicated for the treatment of asthma or as a rescue therapy for acute bronchospasm.

In a joint statement, the companies said they expect to launch the product during the first quarter of 2014. A GSK spokesman declined to disclose pricing information.

In an industry note last week, Jefferies LLC analyst Jeffrey Holford predicted GSK will price Anoro “at a significant premium to Advair (fluticasone/salmeterol) or Breo Ellipta,” since much of the market share for the new drug will be gained from patients who would have been prescribed two branded products. “We would expect Anoro Ellipta to be the market leading LABA/LAMA due to its once-daily dosing, first-to-market status [in the U.S.] and multi-dose DPI device,” he wrote, estimating sales of $1.8 billion in 2020.

Under terms of their LABA collaboration agreement, inked a decade ago, South San Francisco-based Theravance will make a milestone payment of $30 million to GSK, of London, subsequent to the FDA approval, with an additional $30 million payment slated upon the launch of Anoro in the U.S. The potential $545 million partnership called for the companies to pool their respective LABA candidates to develop treatments for respiratory diseases such as asthma and COPD. (See BioWorld Today, Jan. 7, 2003.)

“Coming into 2013, we had a chance in the U.S. for three product approvals and launches,” Theravance CEO Rick Winningham said, citing Vibativ (telavancin) for hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus, as well as the Breo and Anoro products. “We were successful on all three counts.”

Winningham called the approval of Anoro, together with Breo, “the culmination of an extraordinary amount of work.” Once-daily inhaled Breo was approved by the FDA in May and launched in the third quarter. (See BioWorld Today, May 13, 2013.)

GSK and Theravance started with “a very big portfolio of potential compounds” and worked diligently to find the optimal combination of beta agonist, muscarinic antagonist and inhaled corticosteroid, he added.

“The programs, overall, were important to both companies because of the potential impact they could have on patients,” Winningham told BioWorld Today. “That’s what both organizations kept in mind over the years.”

The FDA’s go-ahead for Anoro was all but assured after the agency’s Pulmonary-Allergy Drugs Advisory Committee voted in September 13-0 in favor of efficacy, 10-3 in favor of safety and 11-2 to recommend approval. With typical COPD maintenance therapy including an assortment of LABAs with corticosteroids, anticholinergic agents, combination LABA/anticholinergics, methylxanthines and phosphodiesterase-4 inhibitors, adcom panelists were unanimous about the need for a more effective product. (See BioWorld Today, Sept. 9, 2013, and Sept. 11, 2011.)

The pivotal Phase III program for Anoro Ellipta included seven clinical studies that enrolled almost 6,000 patients with COPD. Among these, GSK accumulated data from two six-month, placebo-controlled Phase III efficacy and safety trials, two six-month active controlled Phase III efficacy and safety trials and a 12-month safety trial. (See BioWorld Today, Feb. 4, 2011, and July 3, 2012.)

FDA approval came on the drug’s PDUFA date.

Like Breo, the Anoro label, which GSK posted online, includes with a boxed warning that LABAs such as vilanterol increase the risk of asthma-related death. Winningham said the label contained no surprises, consistent with the “good, healthy discussion” about the drug’s risk/benefit profile during September’s adcom.

The companies still have an extensive to-do list that includes regulatory review of Anoro in Europe, Japan and other companies. GSK and Theravance continue to pursue the bifunctional muscarinic antagonist beta 2 agonist, or MABA, program in COPD, which they are combining with an inhaled corticosteroid “to get a shot at triple-mechanism therapy,” Winningham said. In addition, their so-called “closed triple” therapy in development would combine Anoro plus the Breo steroid, fluticasone furoate.

On Wednesday, shares of Theravance (NASDAQ:THRX) lost 32 cents to close at $35.75. GSK shares (NYSE:GSK) gained 29 cents, closing at $51.34.