Glenmark Pharmaceuticals said it has received marketing approval for its Ryaltris fixed-dose combination nasal spray in 13 countries in the EU and the UK.
Glenmark is preparing to launch Ryaltris directly into the markets of the Czech Republic, Slovakia, Poland and the UK. Ryaltris will be marketed in the rest of Europe by the Menarini Group under its exclusive license agreement with Glenmark.
Ryaltris (olopatadine 665 mcg and mometasone furoate 25 mcg) is indicated for the symptomatic treatment of seasonal and aperiodic allergic rhinitis in adults and children over 12 years of age. It relieves the symptoms of allergic rhinitis, including stuffy nose, runny nose, itchy nose, sneezing, as well as itchy, red, watery eyes.
Robert Crockart, Commercial Director of Glenmark Pharmaceuticals, said: Allergic rhinitis is both widespread and underreported, making it difficult to diagnose and treat on time. It has an impact on a person’s quality of life and can lead to functional impairments, while increasing the risk of asthma.
This marketing authorization will pave the way for effective and rapid treatment of allergic rhinitis for thousands of patients across Europe. We are already seeing its therapeutic benefits in other areas where Ryaltris has been launched, and we hope to extend this relief to more people around the world.
Glenmark has also partnered with Hikma Pharmaceuticals PLC and Bausch Health to commercialize Ryaltris in the United States and Canada, respectively. In April of this year, Glenmark completed the DCP regulatory process in Europe, allowing approval in 17 countries in the EU and the UK.
In fiscal years 21-22, Glenmark also received regulatory approval for Ryaltris in the Philippines, Zambia, Ecuador and Peru. Ryaltris sales continue to grow well in Australia, South Africa, Ukraine and Uzbekistan.
Glenmark also initiated the commercial launch in Russia in the first quarter of fiscal year 21-22. The company is awaiting regulatory approvals for its filings in various markets in Canada, Brazil, Malaysia, Saudi Arabia and several other emerging markets.
Currently, Ryaltris is under review by the United States Food and Drug Administration (FDA) as a treatment for seasonal allergic rhinitis in the United States. Glenmark’s response to the Agency’s Full Response Letter (CRL) was submitted to the U.S. FDA in July 2021.
Glenmark’s partner in China, Grand Pharmaceutical (China) Co., finalized the Phase 3 protocol for China and submitted the IND application in July 2021. In South Korea, Glenmark is working with its partner Yuhan Corporation, to potentially launch the product by H2, FY21-22.
In addition, the company is working to submit the application for pediatric efficacy supplement in the country. In June 2021, Glenmark’s partner in Australia, Seqirus, received a first positive feedback from the TGA for the extension of pediatric indications.
Glenmark Pharmaceuticals is a global, research-driven pharmaceutical company active in generics, specialties and over-the-counter (OTC) products and operates in more than 50 countries.
The pharmaceutical company posted a 20.7% increase in consolidated net profit to Rs 306.53 crore on a 27.6% increase in net sales to Rs 2,946 crore in the first quarter of fiscal 22 compared to first quarter of fiscal year 21.
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