Glenmark Pharmaceuticals on Thursday said it 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, Glenmark Pharmaceuticals said in a statement.
The nasal spray, which is indicated for symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children over 12 years of age, will be marketed in the rest of Europe by the Menarini Group as part of its exclusive licensing agreement with Glenmark, it added.
Glenmark Pharmaceuticals Chief Commercial Officer Robert Crockart said, ”This marketing approval will pave the way for 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.” 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, he added.
The company said Ryaltris relieves symptoms of allergic rhinitis, including stuffy nose, runny nose, nasal itching, sneezing, as well as itchy, red and watery eyes.
Glenmark said Ryaltris has been well received by the global medical community for the effective treatment of seasonal and perennial allergic rhinitis. Over 4,000 patients globally took part in Ryaltris clinical trials initiated in 2014.
In April this year, Glenmark concluded the decentralised regulatory procedure in Europe, enabling approval in 17 countries across the EU and the UK.
Glenmark further said it has also partnered with Hikma Pharmaceuticals and Bausch Health for the commercialisation of Ryaltris in the US and Canada, respectively. Currently, it is under review with the US Food and Drug Administration (FDA) as a treatment for seasonal allergic rhinitis in the US. The homegrown pharma major said during FY21-22, it has also received regulatory approval for Ryaltris in the Philippines, Zambia, Ecuador and Peru. Sales of the nasal spray continue to progress well in Australia, South Africa, Ukraine and Uzbekistan, it said adding the company has 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,” the statement said.
In China, Glenmark said its partner, Grand Pharmaceutical (China), has finalised the Phase 3 protocol for the country and submitted application in July 2021, while in South Korea, the company is working with its partner Yuhan Corporation, to potentially launch the product by H2, FY21-22. Also, the company is working to submit the application for paediatric efficacy supplement in the country.