European regulators have recommended approval of GlaxoSmithKline’s Avamys, a once-daily nasal spray that treats the symptoms of hay fever, for patients aged six and above.
Avamys (fluticasone furoate) is backed by solid results from a clinical trial programme, which showed its ability to treat the overall nasal allergy symptoms associated with the condition, such as congestion, sneezing, and an itchy/runny nose.
Moreover, according to GSK, the product is the first of its kind to show a “consistently significant improvement in relieving overall eye symptoms”, including red, itchy, burning and watery eyes, for over 24 hours, and thereby offers an important advantage over other therapies on the market.
“Up to 70% of people with allergic rhinitis suffer from symptoms that affect both the nose and the eyes, and Avamys is the only prescription nasal steroid spray that has demonstrated consistent efficacy within clinical studies, in relieving both these symptoms associated with an allergic response,” explained Andrew Witty, President of GSK Pharmaceuticals, Europe and Chief Executive Officer Designate.
Other plus points
But Avamys also ticks boxes on the quality of life and patient-friendly delivery fronts. The group highlighted a study in which adult and adolescents given Avamys reported statistically significant and clinically meaningful improvements in overall allergy-related quality of life scores compared with placebo.
And, with regard to ease of use, GSK says it has designed the drug’s delivery device to address “shortcomings in current nasal sprays identified by patients and physicians”, including a smaller nozzle for a better fit and a viewing window that allows patients to check the level of medicine left in the device.
The product was first approved in the USA earlier this year, where it is sold as Veramyst, and analysts are expecting it to eventually rake in peak sales of $1 billion, so news that it is one step closer to the European market will certainly be welcomed by the firm.