Glenmark’s Ryaltris nasal spray gets approval in Europe for treatment of allergic rhinitis

Glenmark Pharmaceuticals is concluding the final, national phase of its marketing approval application process to enable launch of its nasal spray in 17 countries in the European Union. Ryaltris (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg), 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 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. Under the terms of the agreement, Glenmark is responsible for the continued development and regulatory approval of Ryaltris in these markets, while Menarini will lead the scientific information and commercialisation of Ryaltris, following regulatory approval. Glenmark has received an upfront payment and will additionally receive launch andsales based milestone payments from Menarini for Ryaltris sales.

Ryaltris, developed by Glenmark, is a novel fixed-dose combination nasal spray of an anti-histamine and a steroid, indicated for treatment of symptoms associated with allergic rhinitis (AR) in patients over 12 years of age. It relieves symptoms of allergic rhinitis, including stuffy nose, runny nose, nasal itching, sneezing, as well as itchy, red and watery eyes.

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. Ryaltris sales continue to progress well in Australia, after the successful launch in 2020 by Glenmark’s partner, Seqirus. Ryaltris was also recently launched in South Africa, Ukraine and Uzbekistan. So far, Glenmark has received approval for Ryaltris in Australia, South Korea, Cambodia, Ukraine, Uzbekistan, Namibia, Russia, South Africa, and Ecuador. Ryaltris is currently under regulatory review in Canada, Brazil, Malaysia, Saudi Arabia and several other markets. Glenmark’s partner in China, Grand Pharmaceutical (China), plans to submit an IND in this financial year.