Glenmark Receives Marketing Authorization For Ryaltris®, An Innovative Combination Nasal Spray, In 13 EU And UK Countries
– Ryaltris® is a fixed-dose combination nasal spray that combines an antihistamine (Olopatadine) with a steroid (mometasone furoate) for the treatment of allergic rhinitis
– Ryaltris® has been well received by the global medical community for the effective treatment of seasonal and perennial allergic rhinitis
– To launch in Europe directly by Glenmark and via the partner Menarini
– More than 4000 patients worldwide have participated in Ryaltris® clinical trials initiated in 2014
– Phase 3 efficacy and safety trials show twice-daily treatment with Ryaltris® results in clinically significant improvements in symptoms of allergic rhinitis compared to placebo and component monotherapies
Mumbai, India, September 30, 2021 / PRNewswire / – Glenmark Pharmaceuticals Limited, an integrated global research-driven pharmaceutical company, has received marketing approval for its Ryaltris® fixed-dose combination nasal spray in 13 countries in the EU and the UK. Glenmark to launch Ryaltris® directly into the markets of Czech Republic, Slovakia, Poland, and the United Kingdom. Ryaltris® will be marketed in the rest of the Europe by the Menarini Group under its exclusive license agreement with Glenmark.
Ryaltris® (olopatadine 665 µg and mometasone furoate 25 µg), is indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children over 12 years of age. Ryaltris® relieves symptoms of allergic rhinitis including stuffy nose, runny nose, itchy nose, sneezing, as well as red itch, and watery eyes.
Commenting on this development, Glenmark Pharmaceuticals Limited Commercial Director Mr. Robert crockart said: “Allergic rhinitis is both widespread and underreported, making it difficult to diagnose and treat on time. It has an impact on a person’s quality of life and can lead to functional impairments, while increasing the risk of asthma. This marketing authorization will pave the way for effective and rapid treatment of allergic rhinitis for thousands of patients across Europe. We are already seeing its therapeutic benefits in other areas where Ryaltris® has been launched, and we hope to extend this relief to more people around the world. ”
Glenmark has also partnered with Hikma Pharmaceuticals PLC and Bausch Health for the commercialization of Ryaltris® in the United States and Canada respectively. In April of this year, Glenmark concluded the DCP regulatory process in Europe, allowing approval in 17 countries across the EU and UK.
In fiscal year 21-22, Glenmark also received regulatory approval for Ryaltris® in Philippines, Zambia, Ecuador and Peru. Ryaltris® sales continue to grow well in Australia, South Africa, Ukraine and Uzbekistan. Glenmark also initiated the commercial launch in Russia at T1, FY21-22. The company is awaiting regulatory approvals for its filings in various markets across Canada, Brazil, Malaysia, Saudi Arabia, and several other emerging markets.
Currently, Ryaltris® is under review by the United States Food and Drug Administration (FDA) as a treatment for seasonal allergic rhinitis in the United States. Glenmark’s response to the Agency’s Full Response Letter (CRL) was submitted to the United States FDA in July 2021.
Glenmark partner in China, Large Pharmaceutical (China) Co. Ltd., finalized the Phase 3 protocol for China, and submitted the IND request in July 2021. In South Korea, Glenmark is working with its partner Yuhan Corporation, to potentially launch the product by H2, FY21-22. In addition, the company is working to submit the application for pediatric efficacy supplement in the country. In June 2021, Glenmark partner in Australia,
Seqirus Pty Ltd. received a first positive feedback from the TGA for the extension of pediatric indications.
On the other side Africa, Americas, Asia, and Europe, the prevalence of allergic rhinitis can reach 25%[i]. Symptoms like a stuffy or runny nose, itchy nose, sneezing (sometimes relentless), itching, red or watery eyes can prevent patients from functioning normally for days, or even weeks in many cases, resulting in can have significant health consequences, as good as the quality of life. Poor adherence to available treatments has also been noted in several cases, making Ryaltris® a viable treatment option to counter the challenges posed by allergic rhinitis.
[i] 1Allergy Asia Pac. January 2018; 8 (1): e7
About Glenmark Pharmaceuticals Limited
Glenmark Pharmaceuticals Limited (Glenmark) is a global research-driven pharmaceutical company with a presence in generic, specialty and OTC businesses and with operations in over 50 countries. Glenmark’s main therapeutic areas worldwide are respiration, dermatology and oncology. It ranks among the top 50 generic and biosimilar companies in the world (ranking of the top 50 companies, 2020, according to Informa’s Generics Bulletin). The company is listed on the Dow Jones Sustainability Index (DJSI), in the emerging markets category for the third consecutive year. DJSI is one of the most respected and widely accepted sustainability benchmarks in the world, with only the top-ranked companies for corporate sustainability in each industry listed in the index. For more information, visit www.glenmarkpharma.com
For more information please contact
Deputy Managing Director, Corporate Communication