FDA Approval Veramyst

GlaxoSmithKline PLC
29 April 2007



Issued -  27 April 2007, London, UK & Philadelphia US - LSE Announcement



 FDA Approves Once-Daily Veramyst(TM)(fluticasone furoate) Nasal Spray For The
  Treatment of Seasonal And Year-Round Allergy Symptoms In Adults And Children 
                             As Young As Two Years



      New Treatment Has Shown Benefit in Both Nasal and Ocular Symptoms in
              Seasonal Allergy Patients 12 Years of Age and Older 



GlaxoSmithKline plc today, 27th April 2007, announced that the U.S. Food and
Drug Administration approved once-daily Veramyst(TM) (fluticasone furoate) Nasal
Spray to treat seasonal and year-round allergy symptoms in adults and children
two years of age and older. Veramyst will be available by prescription in the
U.S. by late May 2007.


This is the first regulatory approval of fluticasone furoate nasal spray, which
is currently under regulatory review under the trade name Allermist(TM) in Japan
and under the tradename Avamys(TM) in Europe, Canada, Australia and other
international markets.


The approval of Veramyst was based on clinical trials of more than 2,900 adults
and children who suffer from seasonal or year-round allergies.  Veramyst was
proven effective for relieving overall nasal allergy symptoms, which included
nasal congestion, sneezing, itchy nose and runny nose in patients two years of
age and older with seasonal and year-round allergies. In addition, Veramyst is
the first prescription nasal steroid spray to demonstrate consistent and
significant improvement in relieving overall allergic eye symptoms, which
included red, itchy and watery eyes in patients with seasonal allergies 12 years
of age and older in three prospectively designed studies. In all studies,
Veramyst sustained its effectiveness for a full 24 hours.


In the studies Veramyst was well tolerated in adults and children. Common
adverse reaction included headache, nose bleed and nasal sores. Fever occurred
more frequently in children aged two to 11 years taking Veramyst than in the
placebo group.


"Allergies often affect both the nose and the eyes," said Darrell Baker, Senior
Vice President, Respiratory Medicines Development Center. "Our studies showed
that Veramyst relieved not only a broad range of nasal symptoms but for seasonal
allergy sufferers age 12 and older, it also helped relieve red, itchy, watery
eyes. In addition Veramyst is delivered in a new, unique device, which was
designed with patients' concerns in mind."


The device for Veramyst has been ergonomically designed with a side-actuated
mist release button that releases a gentle, scent-free mist with a low volume of
spray. Veramyst has a commitment feature that ensures delivery of the same
amount of medicine every time, which is important for patients who want to know
that they are getting the full dose their doctor has prescribed.


Veramyst is an intranasal corticosteroid that works early and throughout the
allergy process to block an entire range of chemicals in the body that are
involved in inflammation and lead to nasal allergy symptoms. However, the
precise mechanism through which Veramyst affects allergy symptoms is not known.


About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and
healthcare companies. GlaxoSmithKline is committed to improving the quality of
human life by enabling people to do more, feel better, and live longer.  For
company and prescribing information visit www.gsk.com.


Journalists may access the electronic press kit for more information on Veramyst
at www.gsk.com/media.


S M Bicknell
Company Secretary
27th April 2007


Cautionary statement regarding forward-looking statements  

Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, the company cautions investors that any forward-looking
statements or projections made by the company, including those made in this
Announcement, are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors that may affect the
Group's operations are described under 'Risk Factors' in the 'Business Review'
in the company's Annual Report on Form 20-F for 2006.



Enquiries:

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