Positive Outcome of European Decentralised Registration Procedure for Stallergenes Greer’s Sublingual House Dust Mite Allergen Immunotherapy Tablet
Stallergenes Greer, a biopharmaceutical company specialising in treatments for respiratory allergies, announces the positive outcome of the European decentralised registration procedure for its sublingual house dust mite (HDM) allergen immunotherapy tablet Actair®. The Paul-Ehrlich-Institut (PEI), Germany, acted as reference member state on behalf of 21 European countries. Each member state involved in the procedure will now issue individual national marketing authorisations at the end of their national phase.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210531005167/en/
“We are pleased to have achieved this significant milestone which demonstrates our commitment to patients and marks a major step forward for the company’s further development in the European market. Stallergenes Greer’s sublingual allergen immunotherapy tablet is an important option for people suffering from house dust mite-induced allergic rhinitis or rhinoconjunctivitis and illustrates our engagement to provide patients with a range of administration modes tailored to individual needs and profiles,” declares Michele Antonelli, Chief Executive Officer.
Stallergenes Greer offers a wide range of treatment options and is paving the way for personalised precision medicine-based allergen immunotherapy: tablet and liquid sublingual solutions as well as subcutaneous formulations.
The tablet is already registered in Australia, Japan, New Zealand and South Korea under the brand name Actair® for treatment of moderate to severe house dust mite-induced allergic rhinitis or rhinoconjunctivitis.
This sublingual allergen immunotherapy (SLIT) tablet will strengthen the company’s tablet portfolio in Europe which already includes Oralair®.
About the STAGR320 Clinical Trial
The STAGR320 Phase III clinical trial, which included 1,607 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 STAGR3201. The study results provide the medical community with compelling evidence that STAGR320 induces clinically relevant improvement of rhinitis symptoms in patients with HDM allergy, which ultimately has an impact on all parameters relating to quality of life.
The randomised, double-blind, placebo-controlled trial was the largest Phase III clinical trial conducted to evaluate the treatment of house dust mite allergy1.
About Allergic Rhinitis and STAGR320
Allergic rhinitis is a worldwide disease affecting more than 500 million people, 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 others2,3. Symptoms may be severe and can worsen over time and have a significant impact on quality of life2,3,4,5,6.
STAGR320 is Stallergenes Greer’s sublingual allergen immunotherapy (AIT) tablet for the treatment of HDM-induced allergic rhinitis. Allergen immunotherapy uniquely alters the natural course of respiratory allergies by inducing tolerance in the immune system.
STAGR320 will be marketed under the brand names Actair®, Orylmyte® or Aitmyte® in selected European countries.
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/
1. Demoly P, Corren J, Creticos P, et al. A 300 IR sublingual tablet is an effective, safe treatment for house dust mite–induced allergic rhinitis: An international, double-blind, placebo- controlled, randomized phase III clinical trial. J Allergy Clin Immunol. 2021
2. 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.
3. Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines— 2016 revision. J Allergy Clin Immunol. 2017;140(4):950–8
4. 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.
5. 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.
6. 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.
Tel: +33 (0)1 55 50 26 05
About Business Wire
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
IHMA Opens Microbiology Reference Laboratory in Shanghai, China to Further Support Global Anti-Infective Product Discovery and Development22.9.2021 16:30:00 CEST | Press release
IHMA has opened a microbiology reference laboratory in Shanghai, China in February of 2021. This facility will join IHMA locations in the USA, Switzerland and India to allow the company to provide more robust global support for anti-infective product discovery and development. The China facility will provide microbiology testing to support profiling of new antimicrobial products, antimicrobial resistance surveillance, molecular characterization of resistant organisms, and serve as a central laboratory for clinical trials conducted in China. “We have been working for almost 30 years to maximize our in vitro support for clients who are developing anti-infective products globally. Our facility in China will greatly enhance that effort and support clients wishing to conduct studies in this important market,” said Jack L. Johnson, President/CEO of IHMA. About IHMA: As the leading global microbiology service provider to the biopharmaceutical industry, IHMA utilizes its extensive laboratory a
Workiva Named a Leader Among Governance, Risk, and Compliance Platforms by Independent Research Firm22.9.2021 16:24:00 CEST | Press release
Workiva Inc. (NYSE:WK), today announced that it was classified as a Leader in The Forrester Wave™: Governance, Risk, and Compliance (GRC) Platforms Q3 2021 report. The company’s connected cloud platform enables collaboration and deep integration into existing systems and workstreams to simplify audit, risk and compliance, operational, financial, and non-financial reporting for companies across the globe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005704/en/ Workiva Named a Leader Among Governance, Risk, and Compliance Platforms by Independent Research Firm (Graphic: Business Wire) Evaluating GRC solutions against 25 criteria, Forrester identified 15 vendors available today, and proceeded to research, analyze, and score them. The report summarizes how each provider measures up, and ranks their solutions based on how well they satisfy the current and future needs of audit, risk, and compliance professionals. Workiva
The Scottish National Blood Transfusion Service (SNBTS) to Deploy Biolog-id Smart Storage RFID Kits Nationwide22.9.2021 15:50:00 CEST | Press release
The Scottish National Blood Transfusion Service (SNBTS) – the specialist provider of transfusion medicine in Scotland – will implement the biolog-id blood inventory devices to optimize the management of its blood products across the country. Through this deployment, biolog-id’s cutting-edge technology will streamline the complex inventory and distribution processes of the red blood cells to distant sites, enhancing the visibility and management of those lifesaving products between the Scottish blood centre and each remote blood bank. Designed for healthcare professionals specialized in the transfusion field, the Biolog Transfusion Solution combines RFID enabled devices powered by a proprietary IT engine and electronic labels. Biolog-id’s contactless devices are integrated into SNBTS’ IT transfusion management solution (MAK-SYSTEM – e-TRACELINE), offering real-time visibility of each component at each step of the supply chain. The corner-stone devices of this solution are the RFID Smart
Let’s Build a Digital Future Together: Join us at Dahua Partner Day 2021!22.9.2021 15:45:00 CEST | Press release
Dahua Technology, a world-leading video-centric smart IoT solution and service provider, will hold its 2nd online Dahua Technology Partner Day on October 13th - 14th with the theme “Building a digital future”. Adhering to its strategy of open cooperation, Dahua Technology is committed to creating a win-win ecosystem with leading technology partners around the world. This year, Dahua Technology will join hands with its 22 global partners to discuss interoperability, share industry trends, and explore the future of digitalization and intelligence together. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005395/en/ (Photo: Business Wire) “We are excited to host our second virtual technology partner day. Technologies have evolved fast in the past year, and the needs of digitization and diversified challenges facing different industries today are driving the integration of security companies,” says Mr. Jiaqi Gao, Overseas Ma
Takeda Selects Four New Partners for Annual Global Corporate Social Responsibility (CSR) Program to Help Strengthen Health Systems in Low- and Middle-Income Countries22.9.2021 15:30:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the addition of four partnerships to its Global Corporate Social Responsibility (CSR) Program, which makes long-term commitments to strengthen health systems and improve access to healthcare for all in developing and emerging countries. As part of an annual decision-making process, Takeda employees worldwide voted to add IntraHealth International, Jhpiego, Pathfinder International and the World Food Programme(WFP) as new partners for the Global CSR Program, which now supports 20 programs in 72 countries. Takeda’s commitments to these new partners in FY2021 include: JPY 953 million to IntraHealth International to work with 12 private schools in Mali, Senegal and Niger to increase the number of qualified, trained nurses who can serve rural communities facing a critical shortage of health workers in these countries. Over the next five years, the project will help private schools partner with the public se
DXC Technology Collaborates with Qualtrics to Transform the Modern Workplace Experience22.9.2021 14:30:00 CEST | Press release
DXC Technology (NYSE: DXC) and Qualtrics (Nasdaq: XM) today announced a new collaboration to make the Qualtrics’ EmployeeXM™ experience management platform a part of DXC’s Modern Workplace service solution. Blended with DXC’s Modern Workplace operational data, DXC will capture and integrate experience data from Qualtrics–how employees feel about their technology experience at work–to provide valuable, real-time employee sentiment to drive greater engagement, collaboration and productivity. DXC will be the first to use the Modern Workplace solution internally to transform the digital experiences for its more than 130,000 employees, the majority of whom are working virtually. Qualtrics research has found that employees’ technology experience is playing a larger role in the overall employee experience, particularly as the digital workplace continues to evolve. Over 90% of CIOs believe the IT experience is important when it comes to attracting and retaining talent and building corporate cu
ESI Group: EMPHYSIS – The Missing Link Between Digital Simulation and Embedded Software22.9.2021 14:24:00 CEST | Press release
Regulatory News: ESI Group (Paris:ESI): The research project EMPHYSIS led by Bosch has delivered the new “eFMI standard” for model exchange to accelerate the model-based development of embedded software. On the 15th of September, this international collaborative project gathering 25 industrial and academic partners from different fields (like automotive and information technologies) situated in Belgium, Canada, France, Germany, and Sweden received the ITEA Award of Excellence for this unique achievement. Better code with less effort through “eFMI” - the new model-exchange standard for embedded devices When developing a new function, many engineers learn the hard way that their outstanding knowledge about the physics of their products is not enough by far to develop a function for an embedded target, due to the demanding requirements of safety-critical software, weak CPU magnitude and less memory than expected. While this might result in a never-to-be-realised excellent initial idea of
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