* No increased risk seen with Boehringer's Spiriva Respimat
* New study contrasts with safety concerns raised in 2011
LONDON, Sept 8 A major study on the safety of a
mist inhaler used to treat chronic lung disease has found it
does not increase the risk of patients dying early, in contrast
to an earlier analysis published two years ago.
The reassuring result with a formulation of Boehringer
Ingelheim's Spiriva delivered through its new Respimat device is
good news for the German drugmaker and potentially for others
developing rival products containing so-called LAMA drugs.
Data from the 17,135-patient study, comparing the safety and
efficacy of Spiriva Respimat against a formulation of the drug
given via the older HandiHaler device, were unveiled at the
European Respiratory Society congress in Barcelona on Sunday.
Competitors in the field include GlaxoSmithKline,
whose experimental product Anoro combining a LAMA drug with a
different kind of treatment called a LABA will be assessed by a
U.S. Food and Drug Administration advisory panel on Sept. 10.
The encouraging safety message on Spiriva Respimat may lower
the regulatory hurdle for such new LAMA-containing products,
industry analysts believe.
Several drugmakers are betting that LABA/LAMA inhalers will
become the first choice for chronic obstructive pulmonary
disease (COPD), which causes debilitating breathlessness and
affects more than 200 million people worldwide.
Other companies working on long-acting beta-2-agonist (LABA)
and long-acting muscarinic antagonist (LAMA) combinations
include Novartis, which has an alliance with Vectura
; AstraZeneca, following its recent acquisition
of Pearl Therapeutics; and a partnership of Almirall
and Forest Laboratories.
Boehringer itself also has a LABA/LAMA drug in development.
Current market-leading drugs for COPD include Spiriva and
Spiriva has been on the market since 2002 but concerns about
its safety were aroused in 2011 when a study based on a pooled
analysis of previous trials suggested patients taking it via the
Respimat device increased their risk of dying by 52 percent
compared to those on placebo.
Boehringer and its marketing partner Pfizer disputed
the findings at the time.
The new three-year clinical trial found Respimat was just as
safe as the older HandiHaler inhaler and that COPD patients
enjoyed a median 756 days without a sustained worsening of
symptoms against 719 days among those using the HandiHaler. The
new trial did not include a placebo group.
Boehringer hopes the new company-sponsored trial - one of
the biggest to date in COPD - will draw a line under the safety
question and reinforce the benefits of all Spiriva formulations.
Global sales of Spiriva last year were $4.6 billion.
The outcome is also important for Boehringer's future
ambitions in developing new medicines, including its LABA/LAMA
product, since these also rely on the Respimat device.
The new study, which was sponsored by Boehringer, was
published simultaneously in the New England Journal of Medicine.