Glenmark Pharmaceuticals said that its Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis has received final marketing approval in 13 countries in Europe and the UK. Earlier this year, the company announced that Ryaltris had received approval in 16 European countries and the UK through the decentralized procedure.
According to Glenmark, the Philippines, Zambia, Ecuador, and Peru have also approved Ryaltris during this fiscal year; Canada, Brazil, Malaysia, Saudi Arabia are reviewing marketing applications; and the nasal spray is already marketed in Australia (by Seqirus), Russia, Ukraine, Uzbekistan, and South Africa. In the US, the FDA issued a complete response letter to Glenmark’s NDA for Ryaltris in June 2019, and the company says that it submitted its response in July 2021.
Glenmark will launch the nasal spray itself in Czech Republic, Slovakia, Poland, and the UK; Menarini will market Ryaltris in the remaining European countries. Hikma Pharmaceuticals acquired US distribution rights to Ryaltris in February 2020, and Bausch Health acquired Canadian rights to the nasal spray in March 2021.
According to Glenmark, its Chinese partner Grand Pharmaceutical has submitted an IND for a Phase 3 trial to Chinese authorities and Yuhan Corporation is looking to launch Ryaltris in South Korea by the second half of the 2021-22 fiscal year.
Glenmark Pharmaceuticals Chief Commercial Officer Robert Crockart commented, “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 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.”
Read the Glenmark Pharmaceuticals press release.
