Glenmark receives marketing approval for its nasal spray in 13 countries across EU and UK

Glenmark Pharmaceuticals has received marketing approval for its fixed-dose combination nasal spray Ryaltris in 13 countries across the EU and the UK. The company is set to launch Ryaltris directly in the markets of Czech Republic, Slovakia, Poland and the UK. Ryaltris will be marketed in the rest of Europe by the Menarini Group as part of its exclusive licensing agreement with Glenmark. Ryaltris (olopatadine 665 µg and mometasone furoate 25 µg), is indicated for 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, nasal itching, sneezing, as well as itchy, red and watery eyes, a company statement said.

Commenting on this development, Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals, said, “Allergic rhinitis is both widespread and underreported, making it challenging to diagnose and treat in time. It impacts a person’s quality of life and can lead to functional impairments, while also increasing the risk of asthma. This marketing approval will pave the way for the effective and timely treatment of allergic rhinitis for thousands of patients across Europe. We are already seeing its therapeutic benefits in other regions where Ryaltris has been launched, and we hope to extend this relief to more people across the world.”

Glenmark has also partnered with Hikma Pharmaceuticals and Bausch Health for the commercialisation of Ryaltris in the US and Canada, respectively. In April this year, Glenmark concluded the DCP regulatory procedure in Europe, enabling approval in 17 countries across the EU and the UK, added the statement.

It notified that during FY21-22, Glenmark also received regulatory approval for Ryaltris in Philippines, Zambia, Ecuador and Peru. Ryaltris sales continue to progress well in Australia, South Africa, Ukraine and Uzbekistan. Glenmark also initiated the commercial launch in Russia in Q1, 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.

According to the statement, currently, Ryaltris is under review with the US Food and Drug Administration (FDA) as a treatment for seasonal allergic rhinitis in the US. Glenmark’s response to the agency’s Complete Response Letter (CRL) was submitted to the US FDA in July 2021.

Glenmark’s partner in China, Grand Pharmaceutical (China), finalised the phase-III protocol for China, and submitted the IND application in July 2021. In South Korea, Glenmark is working with its partner Yuhan Corporation, to potentially launch the product by H2, FY21-22. Further, the company is working to submit the application for paediatric efficacy supplement in the country. In June 2021, Glenmark’s partner in Australia, Seqirus received positive initial feedback from the TGA for the paediatric indication expansion. Across Africa, the Americas, Asia and Europe, the prevalence of allergic rhinitis can be as high as 25 per cent, said the statement.