Glenmark Pharmaceuticals has received a significant approval from the US FDA to expand the use of RYALTRIS Nasal Spray for children aged 6 to less than 12 years.
According to a BSE filing, the approval extends the use of RYALTRIS to a younger pediatric population for the treatment of symptoms of Seasonal Allergic Rhinitis. This development strengthens Glenmark’s innovative respiratory portfolio.
The approval was supported by a Phase 3, randomized, double-blind, placebo-controlled study involving 446 children aged 6 to 11 years with Seasonal Allergic Rhinitis.
The study demonstrated that RYALTRIS improved nasal symptoms compared with placebo and was well tolerated over the 14-day treatment period. This milestone marks an important step in expanding access to RYALTRIS in the United States.
The US FDA approval is a significant win for Glenmark, as it extends the use of RYALTRIS to a younger pediatric population. Seasonal allergies are common among school-age children in the United States, affecting not only nasal symptoms but also overall health, emotional well-being, sleep, and participation in physical activity.
As part of its transition to direct commercialization, Glenmark now has greater ownership of the brand, which is expected to boost its sales. The company’s president and business head, North America, Marc Kikuchi, commented on the development, stating that it marks an important step in expanding access to RYALTRIS in the United States.
This approval reinforces Glenmark’s position as a key player in the pharmaceutical sector, with a strong focus on innovative respiratory products.
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