GlaxoSmithKline Plc and Theravance Inc.’s Breo Ellipta should be approved to treat a lung disorder that is the third-leading cause of death in the U.S., advisers to the Food and Drug Administration said.
The companies provided substantial evidence the dry powder inhaler can treat airflow obstruction long-term and reduce exacerbations of chronic obstructive pulmonary disease, a panel of FDA advisers voted today in Silver Spring, Maryland. The agency is expected to decide whether to approve Breo by May 12.
Chronic obstructive pulmonary disease, often caused by cigarette smoking, is an umbrella term for emphysema and chronic bronchitis. Breo would compete with similar twice-daily products Advair, from Glaxo, and Symbicort, from AstraZeneca Plc.
“Looking at the risk/benefit analysis of this, benefit won,” James Tracy, a panel member who is an assistant clinical professor of internal medicine at Creighton University School of Medicine in Omaha, Nebraska, said during the hearing.
The drug may generate $1.3 billion in sales for London-based Glaxo in 2018, the average of five analysts’ estimates compiled by Bloomberg. South San Francisco, California-based Theravance would receive royalties of 15 percent on the first $3 billion of sales and 5 percent on any sales higher, the company’s chief executive officer, Rick Winningham, said in an interview last month.
Glaxo is Theravance’s largest shareholder, owning 27 percent of the company’s shares, according to data compiled by Bloomberg. Theravance shares were halted today for the advisory panel meeting. Glaxo rose less than 1 percent to 1,607 pence at the close of London trading.
Breo is a combination of the compound vilanterol and a corticosteroid. Breo and similar combinations carry side effects, including pneumonia and increased risk of fractures, FDA staff said in a report April 15. FDA staff questioned whether the benefit of Breo, which it called evidence of “less than robust” against vilanterol alone to relax the airways, outweighed the side effects.
Panel members said patients with severe cases of chronic obstructive pulmonary disease who would use the drug would benefit despite the risks.
The panel voted 9-4 Breo should be approved to treat airflow obstruction associated with chronic obstructive pulmonary disease and to reduce exacerbations of the disorder. Advisers also voted 10-3 that Glaxo and Theravance demonstrated the safety of the drug.
A once-daily formulation has better compliance than drugs that must be used more often, Winningham said. Breo would be the first drug to market produced by a Glaxo and Theravance partnership formed more than 10 years ago, he said.
Glaxo should complete this year a study on Breo’s use in asthma that may enable the companies to file an application for review with the FDA for that indication, Winningham said. The companies also are working on another treatment for chronic obstructive pulmonary disease, called Anoro. That once-daily medicine combines vilanterol with another ingredient to improve lung function.
The FDA is expected to decide whether to approve Anoro in December. The drug would compete with Pfizer Inc.’s and Boehringer Ingelheim’s Spiriva.
Theravance generated $136 million in revenue last year while sales are projected to almost triple to $372 million in 2016, according to the average of six analysts’ estimates.