Glaxo Asthma Drug Clears Key Hurdle in Europe

By Denise Roland

LONDON--GlaxoSmithKline PLC's [GSK.LN] new severe-asthma medicine has received a positive opinion from the scientific committee of the European Medicines Agency for use in adults, clearing a key hurdle towards gaining marketing approval in Europe.

If approved, the drug, called mepolizumab, would be the first in a new class known as anti-IL5s, and would be taken as a monthly injection on top of standard treatments.

The drug has been shown in clinical trials to reduce the frequency of attacks in patients with a severe form of the disease known as eosinophilic asthma by 47%.

AstraZeneca PLC and Teva Pharmaceutical Industries Ltd. are also developing anti IL-5 drugs.

Dave Allen, head of respiratory research at Glaxo, said there were currently "very limited treatment options" for patients with eosinophilic asthma. "Many struggle to control their asthma even when taking high doses of inhaled therapies that are often reliant on daily oral corticosteroids, which can cause serious long-term side effects," he said.

Mepolizumab could add 500 million pounds ($763.5 million) to Glaxo's revenue in 2021, according to analysts at Barclays. According to those analysts, there are around two million people with uncontrolled severe asthma in the G7 group of industrialized nations, with 40% to 60% of these having the eosinophilic form.

A Glaxo spokeswoman said the company expected a decision from the EMA in November. U.S. regulators are expected to make a decision on the drug around the same time.

Write to Denise Roland at [e-mail]

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(END) Dow Jones Newswires

September 24, 2015 11:47 ET (15:47 GMT)

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