Glaxo Asthma Drug Clears Key Hurdle in Europe
September 24 2015 - 12:02PM
Dow Jones News
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 denise.roland@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
September 24, 2015 11:47 ET (15:47 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024
