Glenmark Pharmaceuticals said that it plans to launch Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of allergic rhinitis in 16 European Union countries and the UK after finalizing marketing approval. Menarini Group will commercialize Ryaltris in some of the companies, including France, Italy, Spain, and the Balkans, under a December 2020 licensing agreement; Glenmark will market Ryaltris in the remaining countries.
Glenmark Executive VP, Business Head EMEA-L, Achin Gupta, commented, “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% 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.”
According to Glenmark, marketing applications for Ryaltris are under review in several countries, including Canada, Brazil, Malaysia, and Saudi Arabia, and Grandpharma intends to submit an IND in China within this financial year. The Russian Ministry of Health approved the nasal spray earlier this year. Glenmark also reports that Seqirus recently launched Ryaltris in South Africa, Ukraine and Uzbekistan and that Ryaltris is selling well in Australia after a 2020 launch by Seqirus. Rylatris was approved by the TGA in December 2019.
In the US, Hikma Pharmaceuticals acquired distribution rights to Ryaltris in February 2020. The FDA issued a complete response letter to Glenmark’s NDA for Ryaltris in June 2019. Glenmark recently announced that Bausch Health has obtained Canadian rights to the nasal spray.
Read the Glenmark Pharmaceuticals press release.