ALK's ACARIZAX® Data Results in Significant Change to the GINA Asthma Management Strategy: Sublingual Allergy Immunotherapy (SLIT) Recommended as a Treatment Option in Patients With House Dust Mite Al

Hørsholm, Denmark (ots/PRNewswire) -

ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF) today announced that
for the first time, allergy immunotherapy is now recommended as a
treatment option in the Global Initiative for Asthma (GINA) report:
Global Strategy for Asthma Management and Prevention. This global
strategy is a widely recognised practical resource developed to guide
healthcare professionals and policy makers, and represents the latest
clinical evidence and medical practice for the treatment and
management of asthma. The strategy is updated annually based on
review of recent scientific literature by an international panel of
experts on the GINA Science Committee.

(Logo: http://photos.prnewswire.com/prnh/20160420/357628LOGO )

The 2017 update, which includes new information regarding the use
of allergy immunotherapy, has just been released and features the
following addition to steps 3 and 4 of GINA's recommended stepwise
treatment of asthma in adult house dust mite (HDM) sensitive
patients:

Consider adding SLIT (sublingual allergy immunotherapy) in adult
HDM sensitive patients with allergic rhinitis who have exacerbations
despite ICS (inhaled corticosteroids), provided FEV1 is > 70% of
predicted lung function.[1]

This change draws upon recently published results from ALK's Phase
III clinical trial evaluating the treatment of HDM allergic asthma
with the HDM SLIT-tablet, ACARIZAX® in The Journal of the American
Medical Association (JAMA) [2]

Henrik Jacobi, Executive Vice President of Research & Development
at ALK, said: "We are extremely pleased to see the recognition of
ACARIZAX® clinical evidence in the management of asthma. This
confirms our long-held conviction that allergy immunotherapy has an
important role to play in the treatment of allergic asthma, a belief
confirmed by the unprecedented clinical development programme for
ACARIZAX®, currently the only HDM SLIT-tablet indicated for use in
patients with house dust mite allergic asthma that is not well
controlled."

House dust mite allergy and asthma often coexist. More than half
of asthmatic patients have been reported to have house dust mite
sensitisation.

He continued: "ALK is committed to gathering further evidence to
support the wider recognition of allergy immunotherapy as a treatment
option for asthma, and to investigating the potential role for
allergy immunotherapy in preventing the onset of asthma."

Professor J. Christian Virchow, of the University of Rostock and
lead author of the recently published paper in JAMA says: "This is
very encouraging. I am pleased to see findings from this important
trial translated into clinical guidelines. This underlines the
importance of performing robust evidence based trials in allergy
immunotherapy."

ACARIZAX® is currently approved for the treatment in HDM allergic
asthma in 12 European countries and Australia.

ALK-Abelló A/S

About ALK

ALK is a research-driven global pharmaceutical company focusing on
allergy prevention, diagnosis and treatment. ALK is a world leader in
allergy immunotherapy - a treatment of the underlying cause of
allergy. The company has approximately 2,300 employees, with
subsidiaries, production facilities and distributors worldwide. ALK
has entered into partnership agreements with Torii, Abbott, and
Seqirus to commercialise sublingual allergy immunotherapy tablets in
Japan, Russia, and South-East Asia, and Australia and New Zealand,
respectively. The company is headquartered in Hørsholm, Denmark, and
listed on Nasdaq Copenhagen. Find more information at
http://www.alk.net.

About house dust mite allergy and ACARIZAX®

House dust mites (HDM) are the most common cause of allergy in the
world. HDM allergy is estimated to affect around 90 million people in
Europe, North America and Japan, and more than 100 million in China.
It is estimated that one in 10 adults with allergic rhinitis are
poorly controlled with current standard therapies. The condition
appears early in life, is present all year round and patients face an
elevated risk of developing asthma and other allergies. For some of
these patients, the HDM SLIT-tablet is a relevant treatment option
which can improve their quality of life and potentially modify the
underlying cause of their disease.

ALK's HDM SLIT-tablet is a treatment for house dust mite-induced
allergic rhinitis (AR) with or without conjunctivitis and allergic
asthma (AA) that is not well controlled by symptomatic medication. In
Europe, where it is marketed as ACARIZAX®, the product has been
approved in 14 countries for the treatment of AR, 12 of which also
include the HDM AA indication. It is also approved in Japan for AR,
where it is licensed by ALK to Torii and marketed under the trade
name MITICURE[TM] and in Australia for HDM AR and AA, where it is
licensed by ALK to Seqirus. The product is also being developed for a
number of other markets around the world, including China, North
America and countries in Southeast Asia. Altogether, clinical
development activities for the HDM SLIT-tablet have involved more
than 6,000 patients worldwide.

In the 12 European countries where ACARIZAX® has been approved for
HDM AR and AA, ACARIZAX® is indicated in adult patients (18-65 years)
diagnosed by a clinical history and by a positive test for HDM
sensitisation with at least one of the following conditions:

- Persistent moderate to severe HDM allergic rhinitis despite the use
of symptom-relieving medication
- HDM allergic asthma not well controlled by inhaled corticosteroids
and associated with mild to severe HDM allergic rhinitis and where
patients' asthma status has been carefully evaluated before
initiation of treatment.

Asthma relevant contraindications:

- Patients with FEV1 <70% of predicted value at initiation of
treatment
- Patients who have experienced a severe asthma exacerbation within
the last 3 months
- Patients with asthma who are currently experiencing an acute
respiratory tract infection

Treating physicians should refer to full summary of product
characteristics before considering ACARIZAX® for treatment in
patients with house dust mite allergic asthma.[3]

About GINA[4]

GINA was launched in 1993 in collaboration with the National
Heart, Lung, and Blood Institute, National Institutes of Health, USA,
and the World Health Organization. GINA's programme is determined and
its strategies for asthma care are shaped by committees made up of
leading asthma experts from around the world.

The GINA Scientific Committee prepares updates to their reports
and guidelines each year, which are made available on the GINA
Website as they are completed. The Scientific Committee has developed
a sophisticated set of procedures to review the world's literature
with regards to asthma management and to update the GINA documents to
reflect this state-of-the-art information.

References:

1. GINA, Global Strategy for Asthma Management and Prevention (2017
update), http://ginasthma.org/
2. Virchow JC, Backer V, Kuna P, et al. JAMA 2016;315(16):1715-25.
doi: 10.1001/jama.2016.3964
3. ACARIZAX® 12 SQ-HDM oral lyophilsate Summary of Product
Characteristics. ALK Abello A/S, August 2015
4. http://ginasthma.org/

ots Originaltext: ALK
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Original-Content von: ALK, übermittelt durch news aktuell