Glenmark Pharma on Monday said it is concluding the final, national phase of its marketing approval application process to launch its nasal spray Ryaltris in 17 countries in the European Union (EU).
Glenmark said Ryaltris is now approved in Europe for the first line treatment of allergic rhinitis in patients over 12 years of age.
Ryaltris is indicated for symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children over 12 years of age. The drug relieves symptoms of allergic rhinitis, including stuffy nose, runny nose, nasal itching, sneezing, as well as itchy, red and watery eyes.
The company is concluding the final, national phase of its marketing approval application process to enable launch of its innovative nasal spray in 17 countries in the EU. Ryaltris will shortly be available in Austria, Belgium, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Italy, The Netherlands, Norway, Poland, Romania, Slovakia, Sweden, and the UK, Glenmark Pharma said in a regulatory filing.
Glenmark said it will commercialise Ryaltris on its own in select markets.
“In some countries such as France, Italy, Spain and the Balkan region, Menarini Group will lead the commercialisation effort, as part of an exclusive licensing agreement signed with Glenmark in 2020,” the company added.
Achin Gupta, Executive Vice President, Business Head EMEA-L (Europe, Middle East, Africa, Latam) Glenmark Pharmaceuticals, said, “Despite many treatments being available for allergic rhinitis, Glenmark is excited to launch Ryaltris as the only first line combination inhaler treatment option for patients across Europe. Upwards of 25 per cent of the population in Europe suffers from the debilitating symptoms of allergic rhinitis, so we hope that Ryaltris will bring some of these real benefits – a simple inhaler, offering fast and effective relief.”
Glenmark has also partnered with Hikma Pharmaceuticals and Bausch Health for the commercialisation of Ryaltris in the US and Canada, respectively.