Glaxo's Lung Drug Anoro Recommended by Europe Regulator

GlaxoSmithKline Plc said the lung drug Anoro, a follow-up medicine to its best-selling Advair, was recommended for approval by Europe’s drug regulator.

Anoro was recommended by the European Medicines Agency as a once-daily treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease, the London-based company said in a statement today. The drug was approved in the U.S. in December.

Anoro may help Glaxo protect its respiratory business, which made up 42 percent of its total pharmaceutical sales last year. The company’s top-selling product, Advair for smokers’ cough and asthma, is facing increasing competition from a newly approved generic in Europe and cheaper options in the U.S. Glaxo also won approval last year for Breo, a separate drug for COPD.

Anoro, a once-daily dry powder inhaler, may generate $1.25 billion in sales in 2016, according to the average of seven analysts’ estimates compiled by Bloomberg. COPD is a disease often caused by smoking, that makes it difficult to breathe.

Anoro will compete with Novartis AG’s Ultibro Breezhaler, which works in a similar way. Novartis has also been winning approval for AirFluSal, a generic form of Advair, since December in European markets such as Germany and Denmark through a decentralized country-by-country process.

COPD kills a person every 10 seconds and will become the third leading cause of death worldwide by 2030, according to the World Health Organization and Glaxo. Conditions known as chronic bronchitis and emphysema are both included in the COPD diagnosis. While asthma affects more people globally, it doesn’t kill on the scale of COPD, according to the WHO.

The market for COPD medicines may rise to $14 billion in 2018 from $10 billion this year, Citigroup Inc. analysts estimate. Including asthma, the respiratory market will total more than $30 billion, according to Bloomberg Industries.

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