Pharma powerhouse Glenmark Specialty has secured US FDA nod that paves the use of its RYALTRIS nasal spray for treating symptoms of seasonal allergic rhinitis (SAR) in children aged 6 to 12 years.

 

The expanded indication is backed by results from a Phase 3 randomized, double-blind, placebo-controlled study involving 446 children aged 6 to 11 years with Seasonal Allergic Rhinitis. 

 

The study showed that RYALTRIS (olopatadine hydrochloride and mometasone furoate) significantly improved nasal symptoms compared with placebo and was well tolerated throughout the 14-day treatment period.

 

The latest FDA decision also marks another milestone for Glenmark's US respiratory franchise following its transition to direct commercialization of RYALTRIS earlier this year.

 

Commenting on the approval, Marc Kikuchi, President & Business Head, North America said, "This approval marks an important step in expanding access to RYALTRIS in the United States by extending its use to children aged 6 to less than 12 years with Seasonal Allergic Rhinitis. It also strengthens the role of RYALTRIS as a key innovative brand within Glenmark’s growing US respiratory portfolio."

 

“Our transition to direct commercialization gives us greater ownership of the brand and enables closer engagement with healthcare professionals and patients. We intend to use this platform to expand access, build the RYALTRIS franchise and further strengthen Glenmark’s innovation-led presence in the U.S. specialty market,” he added.