Stallergenes Greer Submits a Marketing Authorisation Application in Europe for Its Sublingual House Dust Mite Allergen Immunotherapy Tablet
Stallergenes Greer, a biopharmaceutical company specialising in treatments for respiratory allergies, announces the submission of a marketing authorisation application for STAGR320, its sublingual house dust mite (HDM) immunotherapy (SLIT) tablet, via a European decentralized procedure.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200504005266/en/
“By further developing its portfolio of allergen immunotherapy solutions, Stallergenes Greer enables physicians and patients to determine the treatment alternative that best meets the clinical and immunological profile and the lifestyle needs of each individual. This significant milestone demonstrates our determination to offer patients and the medical community an extensive portfolio of personalised treatment options including injectable and sublingual therapies such as drops and tablets,” stated Michele Antonelli, CEO of Stallergenes Greer.
The STAGR320 phase III clinical trial, which included 1,600 patients from 231 participating investigative sites in 13 countries, assessed the treatment of HDM-induced allergic rhinitis in adult and adolescent patients. The trial achieved both its primary efficacy endpoint and key secondary endpoints and showed a comparable safety profile to that observed in other clinical studies with STAGR320. The randomized, double-blind, placebo-controlled trial was the largest phase III clinical trial conducted to evaluate the treatment of house dust mite allergy.
Allergic rhinitis affects more than 500 million people worldwide, who are at higher risk of developing rhinitis exacerbation and asthma than the general population. Allergic rhinitis can include symptoms such as sneezing, a runny or itchy nose, nasal congestion and watery or itchy eyes, among others1,2. Symptoms may be severe and can worsen over time and have a significant impact on quality of life1-3,4-5.
ABOUT STAGR320
STAGR320 is Stallergenes Greer’s investigational sublingual allergen immunotherapy (AIT) tablet for the treatment of HDM-induced allergic rhinitis, with or without intermittent asthma. Allergen immunotherapy uniquely alters the natural course of respiratory allergies. It is the only therapeutic class capable of modifying disease progression and potentially preventing the onset of the disease by inducing tolerance in the immune system. STAGR320 is registered under the brand name Actair® in Australia, Japan, New Zealand and South Korea for the treatment of HDM-induced allergic rhinitis in adults and adolescents. The indication is extended in Japan for use in children below 12 years of age.
The review by Health Canada of the New Drug Submission for STAGR320 is underway.
Stallergenes Greer’s STAGR320 HDM sublingual immunotherapy tablet strengthens the company’s tablet portfolio, which already includes Oralair® for the treatment of grass pollen allergies. STAGR320 contains the same active ingredient as the company’s Staloral® HDM sublingual solution formulation. Stallergenes Greer’s wide range of treatment options provides physicians with solutions tailored to the needs of each patient: sublingual tablet formulation for ease of use and convenience, and sublingual solution for flexible dosing according to each individual profile.
ABOUT STALLERGENES GREER Ltd
Headquartered in London (UK), Stallergenes Greer Ltd is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer Ltd is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France).
Additional information is available at https://www.stallergenesgreer.com/
REFERENCES
1. Bousquet J, Khaltaev N, Cruz A, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160.
2. Brożek JL, Bousquet J, Agache I, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) Guidelines – 2016 Revision, Journal of Allergy and Clinical Immunology (2017), doi: 10.1016/j.jaci.2017.03.050.
3. Linneberg A., Henrik Nielsen N., Frolund L, et al. The link between allergic rhinitis and allergic asthma: a prospective population-based study. The Copenhagen Allergy Study. Allergy. 2002 Nov;57(11):1048-1052.
4. Shin J-W, Sue J-H, Song T-W, et al. Atopy and house dust mite sensitization as risk factors for asthma in children. Yonsei Med J.2005;46: 629-634.
5. Hankin C. S., Cox L., Lang D.,et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective, matched cohort study. Ann Allergy Asthma Immunol. 2010 Jan;104(1):79-85.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200504005266/en/
Contact information
Communications
Catherine Kress
Tel: +33 01 55 59 26 05
Email: catherine.kress@stallergenesgreer.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IonQ and CCRM Announce Strategic Quantum-Biotech Collaboration to Accelerate Development of Advanced Therapeutics1.12.2025 14:30:00 EET | Press release
IonQ (NYSE: IONQ), the world’s leading quantum company, today announced an investment partnership with the Centre for Commercialization of Regenerative Medicine (CCRM) to accelerate next-generation therapeutic development using hybrid quantum and quantum-AI technologies. The partnership includes an investment commitment into CCRM’s new quantum-biotech initiatives and establishes IonQ as the core technology partner across CCRM’s global network of advanced therapy hubs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251201706303/en/ IonQ serves as strategic quantum technology partner across CCRM’s leading global regenerative medicine network. With more than 100,000 square feet of good manufacturing practice (GMP) facilities, 300+ scientific staff and a global network of academic and industry partners, CCRM is one of the world’s leading accelerators for advanced therapies. CCRM was established in 2011 in Toronto, Canada, to rea
Ares Management Introduces Marq to Further Unify its Global Logistics Platform Within its Real Estate Business1.12.2025 13:00:00 EET | Press release
Ares Management Corporation (NYSE: ARES) (“Ares”), a leading global alternative investment manager, announced today that it is consolidating its global logistics real estate platforms under a single brand, Marq Logistics (“Marq”). The newly launched brand, Marq, will represent Ares’ vertically integrated global logistics real estate platform managing facilities that total more than 600 million square feet across the Americas, Europe and APAC. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251201173799/en/ Marq brings together Ares’ vertically integrated logistics real estate platform in North America and Europe, including Ares Industrial Management, with the global GLP logistics real estate platform outside of China. This follows Ares’ acquisition of the international business and certain affiliates of GLP Capital Partners Limited, which closed in March 2025. With Marq, Ares combines its scale, expertise and integrated logis
Prodalim Continues Its Accelerated Strategic Transformation With the Acquisition of René Laurent, a Leading Beverage Flavours Company Based in Grasse area, France1.12.2025 12:42:00 EET | Press release
Prodalim, a global leader in Juice and specialty ingredients solutions, announced today the acquisition of René Laurent, a leading beverage flavours company, from International Flavours & Fragrances Inc. (IFF). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126582710/en/ René Laurent site, Le Cannet, France Established in 1885 in Grasse area, the capital of the flavours and fragrances industry in southern France, René Laurent is a century-old, trusted brand specializing in beverage flavours solutions and unique aromatic Ingredients. The company partners with leading multinational customers and local champions in the beverage industry, offering deep expertise in complex, tailor-made flavour development, including syrups, liqueurs, naturals and coffee. Its extensive flavour library and distinctive in-house distillation and extraction capabilities make René Laurent a respected expert in complex and customized formulations. R
PUMA Opens its Biggest European Flagship Store in the Heart of London, Bringing the Best of the Brand Closer to Consumers1.12.2025 10:00:00 EET | Press release
PUMA has opened the doors to its largest-ever European flagship store on Oxford Street in London, which will bring the best of the company’s products and immersive storytelling closer to consumers in one of the busiest shopping destinations in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251201979895/en/ PUMA has opened the doors to its largest-ever European flagship store on Oxford Street in London, which will bring the best of the company’s products and immersive storytelling closer to consumers in one of the busiest shopping destinations in Europe. The new flagship store, located just seconds from Selfridges and Bond Street Tube Station, spans 24,000 square-feet and features PUMA’s industry-leading innovations, such as running technology NITRO™, its football boots FUTURE, ULTRA and KING, as well as its current range of lifestyle products. “The opening of our Oxford Street flagship is an exciting moment for PUMA,
Wayve Acquires Quality Match to Strengthen Data Quality and Safety for AI Driving Systems1.12.2025 10:00:00 EET | Press release
Wayve, the leader in Embodied AI for autonomous driving, today announced the acquisition of Quality Match, a German startup known for its expertise in data quality assurance for computer vision datasets and artificial intelligence. This acquisition reflects Wayve's continued investment in data accuracy as a cornerstone of safe and scalable autonomous driving. Founded in 2019, Quality Match brings deep expertise in interpreting and analysing data used to train AI models for applications such as advanced assisted and automated driving. As Wayve advances toward the commercial deployment of its AI Driver software, integrating Quality Match strengthens its ability to efficiently develop high-quality, auditable datasets that are essential for building reliable and explainable AI models. Quality Match’s team of 20 specialists, based in Germany, will join Wayve's global operations. The acquisition expands Wayve's presence in the country following the launch of its Testing and Development Hub n
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom