Glenmark’s innovative nasal spray gets EU marketing approval

INDIA – Glenmark Pharmaceuticals has announced that its fixed-dose combination nasal spray, Ryaltris, has received marketing approval in 13 countries across the EU and the UK, bolstering the company’s respiratory therapy line.

Glenmark is a global research-led pharmaceutical company with operations in over 50 countries and a presence in generics, specialty, and over-the-counter (OTC) businesses. Glenmark’s primary therapeutic focus areas include respiratory, dermatology, and oncology.

In terms of revenue, it is ranked among the top 80 Pharma & Biotech companies in the world.

Ryaltris is a combination of antihistamine plus steroid nasal spray indicated for treatment of symptoms associated with allergic rhinitis (AR) and rhinoconjunctivitis in patients over 12 years of age.

It works by relieving allergic rhinitis symptoms such as stuffy nose, runny nose, nasal itching, sneezing, and itchy, red, and watery eyes.

The global medical community has praised it for its efficacy in treating seasonal and perennial allergic rhinitis in adults and children aged 12 years and above.

Chief Commercial Officer of Glenmark Pharmaceuticals Limited, Mr 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.”

Glenmark intends to launch Ryaltris directly in Europe, as well as through a partner, the Menarini Group, which will be responsible for commercializing the drug in 33 European countries, including the Balkan region.

The Indian pharma giant has also collaborated with Hikma Pharmaceuticals and Bausch Health to commercialize Ryaltris in the United States and Canada, respectively.

Ryaltris sales are brisk in Australia, following the successful launch last year by Glenmark’s partner, Seqirus Pty Ltd.

Glenmark managed to complete the decentralized regulatory procedure in Europe in April of this year, allowing approval in 17 countries across the EU and the UK.

Commenting on this development, Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals said, “The 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.”

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