30th Apr 2007 07:00
GlaxoSmithKline PLC29 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 andDrug Administration approved once-daily Veramyst(TM) (fluticasone furoate) NasalSpray to treat seasonal and year-round allergy symptoms in adults and childrentwo years of age and older. Veramyst will be available by prescription in theU.S. by late May 2007. This is the first regulatory approval of fluticasone furoate nasal spray, whichis currently under regulatory review under the trade name Allermist(TM) in Japanand under the tradename Avamys(TM) in Europe, Canada, Australia and otherinternational markets. The approval of Veramyst was based on clinical trials of more than 2,900 adultsand children who suffer from seasonal or year-round allergies. Veramyst wasproven effective for relieving overall nasal allergy symptoms, which includednasal congestion, sneezing, itchy nose and runny nose in patients two years ofage and older with seasonal and year-round allergies. In addition, Veramyst isthe first prescription nasal steroid spray to demonstrate consistent andsignificant improvement in relieving overall allergic eye symptoms, whichincluded red, itchy and watery eyes in patients with seasonal allergies 12 yearsof 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. Commonadverse reaction included headache, nose bleed and nasal sores. Fever occurredmore frequently in children aged two to 11 years taking Veramyst than in theplacebo group. "Allergies often affect both the nose and the eyes," said Darrell Baker, SeniorVice President, Respiratory Medicines Development Center. "Our studies showedthat Veramyst relieved not only a broad range of nasal symptoms but for seasonalallergy sufferers age 12 and older, it also helped relieve red, itchy, wateryeyes. In addition Veramyst is delivered in a new, unique device, which wasdesigned with patients' concerns in mind." The device for Veramyst has been ergonomically designed with a side-actuatedmist release button that releases a gentle, scent-free mist with a low volume ofspray. Veramyst has a commitment feature that ensures delivery of the sameamount of medicine every time, which is important for patients who want to knowthat they are getting the full dose their doctor has prescribed. Veramyst is an intranasal corticosteroid that works early and throughout theallergy process to block an entire range of chemicals in the body that areinvolved in inflammation and lead to nasal allergy symptoms. However, theprecise mechanism through which Veramyst affects allergy symptoms is not known. About GlaxoSmithKline GlaxoSmithKline is one of the world's leading research-based pharmaceutical andhealthcare companies. GlaxoSmithKline is committed to improving the quality ofhuman life by enabling people to do more, feel better, and live longer. Forcompany and prescribing information visit www.gsk.com. Journalists may access the electronic press kit for more information on Veramystat www.gsk.com/media. S M BicknellCompany Secretary27th April 2007 Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities LitigationReform Act of 1995, the company cautions investors that any forward-lookingstatements or projections made by the company, including those made in thisAnnouncement, are subject to risks and uncertainties that may cause actualresults to differ materially from those projected. Factors that may affect theGroup's operations are described under 'Risk Factors' in the 'Business Review'in the company's Annual Report on Form 20-F for 2006. Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 Joss Mathieson (020) 8047 5502 Gwenan White (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Alice Hunt (215) 751 7709 Mary Anne Rhyne (919) 483 2839 European Analyst/Investor enquiries: Anita Kidgell (020) 8047 5542 David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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