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
Lattice to Showcase Advanced Edge AI Solutions at the FPGA-forum 202628.1.2026 23:00:00 EET | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced its exhibition plan for the upcoming FPGA-forum 2026 taking place February 11 – 12, 2026 in Trondheim, Norway. As part of the event, Lattice Corporate Vice President of Software Solutions and Applications Engineering Eleena Ong will deliver a keynote presentation exploring how rapidly maturing AI technologies can turn FPGA platforms into innovation canvases for a much broader range of developers, sparking new application possibilities. Lattice will also deliver a technical presentation and host a demo showcase focused on how its low power FPGA solutions are advancing connectivity and edge AI applications. Who: Lattice Semiconductor What / When (GMT+1): Lattice Demo Showcase (Table #3), Feb 11-12 Keynote Feb. 11, 9:30 a.m. “Unlocking the Next Wave of FPGA Innovators with Generative and Agentic AI” Technical Presentation Feb. 12, 10 a.m. “Smaller. Cooler. Smarter: Lattice FPGAs’ Path to Uncompromised
Egon Zehnder Elects German Herrera as New Chair28.1.2026 21:01:00 EET | Press release
Egon Zehnder, the world’s premier leadership advisory firm, today announced that, in accordance with its established governance and three-year election cycle, German Herrera has been elected as the Firm’s next Chair by its worldwide partnership. Herrera will assume the role effective March 1, 2026. He will succeed Michael Ensser, who has held the position since 2022, in a planned succession at the conclusion of his regular term. Herrera joined the Firm in 1998 in Bogotá and has helped shape the Firm’s global presence, taking on a broad range of leadership roles, from co-leading the Global Family Business Advisory Practice to serving on the Executive Committee and the Market Council. Most recently, Herrera has guided Egon Zehnder’s U.S. market through a period of impressive growth and transformation, which today includes 15 offices and more than 150 consultants. As the first Latinx person in this role in the industry, he actively forges strategic partnerships and joint ventures. With ex
De' Longhi Group - Record Preliminary 2025 Revenues of €3.8 Billion, up 10.4% at Constant Exchange Rates28.1.2026 20:25:00 EET | Press release
Below are the preliminary 2025 revenues for the De’ Longhi S.p.A. Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128191504/en/ 12 months, revenues at € 3,801.5 million, growing at 8.7% (+10.4% at constant currency); fourth quarter, revenues at € 1,340.0 million, growing at 5.7% (+8.2% at constant currency). Fabio de' Longhi, CEO of the Group, stated: "The Group achieved solid growth at constant currency of 10.4% in 2025, characterized by consistent results throughout the year. We are particularly pleased with the excellent performance achieved in the fourth quarter, which successfully overcame the challenges posed by the current market environment. The household division consolidated its recent growth momentum during the quarter, with organic growth of 5.2% against a challenging year-over-year comparison. This performance was primarily driven by the structural trend in coffee, amplified by strategic media investmen
Organon Completes Divestiture of JADA ® System to Laborie28.1.2026 19:45:00 EET | Press release
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today the successful closing of the sale of its JADA® System to Laborie Medical Technologies Corp. Please see our prior announcement for a summary of the transaction terms. Indications for Use The JADA® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. Contraindications Ongoing intrauterine pregnancy Untreated uterine rupture Unresolved uterine inversion Current cervical cancer Known uterine anomaly Current purulent infection of vagina, cervix, or uterus For C-sections: Cervix <3 cm dilated before use of JADA Warnings Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation. The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uter
Laserfiche Expands AI Data Capture with Auto-Classification to Transform Data into Business Intelligence28.1.2026 17:00:00 EET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — today announced major enhancements to its AI-powered data extraction tool, Smart Fields. The update introduces automated document classification and tagging, allowing organizations to move from unstructured content to informed decisions in seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128228490/en/ Using natural language prompts instead of rigid, ruled-based OCR, Smart Fields can now identify document type — such as invoices, taxpayer identification forms, or student transcripts — and automatically apply the correct metadata template using AI. Users can also use Smart Fields to automatically add informational and security tags to files that meet certain criteria, defined using a natural language prompt. Users can capture key details, route documents, and apply the proper metadata tags instantly and at scale. “Success in today’s AI-driven
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