Synopsis :
With this NDA approval, the company looks forward to bringing this new medicine to physicians and their patients for the treatment of symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms, said Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals
Glenmark Pharmaceuticals today said its subsidiary has received approval from the US health regulator to market Ryaltris, a nasal spray for the treatment of seasonal allergic rhinitis. The company’s fully-owned unit Glenmark Specialty SA (Switzerland) has received approval from the US FDA for its New Drug Application (NDA) for Ryaltris, a fixed-dose (metered), prescription, combination nasal spray, Glenmark Pharmaceuticals said in a statement. The product is used for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older, it added.
Glenmark gets US FDA nod for Nasal Spray to treat seasonal Allergic Rhinitis
“The FDA’s approval of Ryaltris represents a major milestone for Glenmark and clearly supports our efforts to bring innovative treatment options in our key therapeutic areas,” said Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals. With this NDA approval, the company looks forward to bringing this new medicine to physicians and their patients for the treatment of symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms, he added. Ryaltris will be marketed and distributed in the United States by Hikma Specialty USA, Inc, as part of its exclusive licensing agreement with Glenmark Specialty SA. Ryaltris has been approved and is marketed in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the UK and Uzbekistan.
In April 2021, Glenmark concluded the regulatory procedure in Europe, enabling approval in 17 countries across the EU and the UK. The drug firm has entered into commercial agreements with several partners around the world, including Menarini for the commercialisation of the drug in select EU markets and with Bausch Health in Canada.
The product is used for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older, it added.
The FDA’s approval of Ryaltris represents a major milestone for Glenmark and clearly supports our efforts to bring innovative treatment options in our key therapeutic areas,” said Robert Crockart, Chief Commercial Officer of Glenmark Pharmaceuticals Limited.
With this NDA approval, the company looks forward to bringing this new medicine to physicians and their patients for the treatment of symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms, he added.
Ryaltris will be marketed and distributed in the United States by Hikma Specialty USA, Inc, as part of its exclusive licensing agreement with Glenmark Specialty SA.
Ryaltris has been approved and is marketed in Australia, the Czech Republic, Poland, Russia, South Africa, Ukraine, the United Kingdom, and Uzbekistan.
In April 2021, Glenmark concluded the regulatory procedure in Europe, enabling approval in 17 countries across the EU and UK.
The drug firm has entered into commercial agreements with several partners around the world, including Menarini for the commercialisation of the drug in select EU markets and with Bausch Health in Canada. The product is under review by Health Canada). The product is under review by Health Canada).
About Glenmark Pharma
Glenmark Pharmaceuticals Limited is an Indian pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons. The company initially sold its products in India, Russia, and Africa. The company went public in India in 1999, and used some of the proceeds to build its first research facility. Saldanha’s son Glenn took over as CEO in 2001, having returned to India after working at PricewaterhouseCoopers. By 2008 Glenmark was the fifth-biggest pharmaceutical company in India.
By 2011 the founder of the company was one of the richest men in India, and Glenmark had worldwide sales of $778 million, a 37% increase over the last year’s sales; the growth was driven by Glenmark’s entry into the US and European generics markets.
In the mid-2010s the generics industry in general began transitioning to the end of an era of giant patent cliffs in the pharmaceutical industry; patented drugs with sales of around $28 billion were set to come off patent in 2018, but in 2019 only about $10 billion in revenue was set to open for competition, and less the next year. Companies in the industry responded with consolidation or trying to generate new, patented drugs.
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