Stallergenes Greer Submits a Marketing Authorisation Application in Europe for Its Sublingual House Dust Mite Allergen Immunotherapy Tablet
4.5.2020 10:00:00 EEST | Business Wire | Press release
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
Ras Al Khaimah Ruler Awards Sheikh Saud International Prize for Materials Science at IWAM 20264.2.2026 15:09:00 EET | Press release
His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, today awarded the Sheikh Saud International Prize for Materials Science during the 17th International Workshop on Advanced Materials (IWAM), one of the world’s leading forums for advanced materials research. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260204274737/en/ HH Sheikh Saud bin Saqr Al Qasimi-keynote speech at IWAM (Photo: AETOSWire) Presented on day two of IWAM, the Prize recognizes exceptional contributions to materials science and its applications in addressing global challenges. The award was conferred upon Professor Omar Yaghi, winner of the 2025 Nobel Prize in Chemistry, in recognition of his transformative work in materials chemistry and his pioneering contributions to clean energy, carbon capture and sustainable technologies. The Sheikh Saud Prize reflects His Highness’s belief in science as a cornerstone
Positron AI Raises $230 Million Series B at Over $1 Billion Valuation to Scale Energy-Efficient AI Inference4.2.2026 15:00:00 EET | Press release
Positron AI, the leader in energy-efficient AI inference hardware, today announced an oversubscribed $230 million Series B financing at a post-money valuation exceeding $1 billion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260204250472/en/ Thomas Sohmers (L), CTO and cofounder, and Mitesh Agrawal (R), CEO of Positron AI (Credit: Kavita Agrawal) The round was co-led by ARENA Private Wealth, Jump Trading, and Unless, and includes new and strategic investment from Qatar Investment Authority (QIA), Arm, and Helena. Existing investors Valor Equity Partners, Atreides Management, DFJ Growth, Resilience Reserve, Flume Ventures, and 1517 also participated. The financing validates Positron's mission to make AI inference dramatically cheaper and more energy-efficient at scale. “We're grateful for this investor enthusiasm, which itself is a reflection of what the market is demanding,” said Mitesh Agrawal, CEO of Positron AI. “Energ
Bridger Photonics Posts Record Year as Operators Turn to Trusted Emissions Intelligence4.2.2026 14:20:00 EET | Press release
Bridger Photonics (“Bridger”) closed its strongest year in company history last year, marked by record asset coverage, record revenue, and global adoption of its methane emissions data and intelligence across multiple continents and the entire oil and natural gas value chain. Bridger’s momentum reflects a clear shift in how operators choose to manage emissions: away from legacy and weather-limited approaches and toward entire asset coverage with data they can trust. Bridger continues to lead the methane detection space—growing existing customers and attracting new ones. Bridger has competitively displaced 32 customers from other aerial technologies, driven by deep industry expertise, proven data reliability and actionability, the ability to operate across challenging conditions and seasons, close coordination with ground crews, and a white-glove service model designed around operator needs. Customers across onshore production, midstream, LNG, and offshore operations are increasingly re
Macrobond Launches Macrobond Amplify, A New Standard for Interactive Financial Research4.2.2026 14:00:00 EET | Press release
Macrobond, the global platform for macroeconomic and financial data, announced the launch of Macrobond Amplify, a browser-based research distribution tool that enables economists and analysts to deliver rich, interactive content to their consumers at scale. Amplify empowers analysts and research teams to move beyond static charts and PDFs, delivering interactive, explorable insights that build trust, foster collaboration, and drive better decision-making. With Amplify, research teams can publish interactive, auditable research models that clients can explore directly through charts and dynamic visualizations. By sharing a simple link, Amplify users can distribute their research at scale with both internal partners and clients. “As the research industry evolves, analysts and economists face growing pressure to ensure their work reaches the right audiences, shows transparency, and demonstrates the rigour behind their thinking,” says Dan Seal, Chief Product Officer at Macrobond. “Amplify
Registrar Corp Acquires TechniCAL and Becomes the Global Compliance Leader in Shelf-stable Packaged Foods Safety4.2.2026 14:00:00 EET | Press release
Registrar Corp, the world’s largest food and beverage regulatory compliance provider, today announced its acquisition of TechniCAL, the world’s leading independent Process Authority for low-acid and acidified foods. Registrar Corp is a Paine Schwartz Partners portfolio company. Consumer demand for convenience and longer product life without refrigeration has driven rapid growth in shelf-stable foods and beverages, with packaging innovations extending beyond cans and glass jars to formats such as retort pouches and cartons. Ensuring products in these various packaging formats are safe from harmful microorganisms is critical to public health and required by the U.S. FDA. Together, Registrar Corp and TechniCAL provide the industry’s most complete solution, combining proven scientific expertise, regulatory knowledge, training, and advanced thermal testing. “TechniCAL is world renowned for its Process Authority expertise and advanced testing technologies assuring compliant thermal processin
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