• Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Data Privacy
  • Sign Up
  • Send a Release
Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • News
  • Products
    • Overview
    • Content Distribution
    • Multimedia Services
    • Disclosure Services
    • Cision Communications Cloud®
  • Contact
    • General Enquiries
    • Media Enquiries
    • Partnerships
    • Worldwide Offices

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases
      • All Public Company News
      • All Multimedia News


      • View All News Releases
      • Regulatory News
      • D/A/CH Regulatory News
      • UK Regulatory News


      • View All Regulatory News
  • Business & Money
      • Auto & Transportation
      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation


      • View All Auto & Transportation
      • Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors


      • View All Business Technology
      • Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • View All Entertain­ment & Media
      • Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Stock Offering
      • Stock Split
      • Venture Capital


      • View All Financial Services & Investing
      • General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News


      • View All General Business
  • Science & Tech
      • Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications


      • View All Consumer Technology
      • Energy & Natural Resources
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities


      • View All Energy & Natural Resources
      • Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters


      • View All Environ­ment
      • Heavy Industry & Manufacturing
      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco


      • View All Heavy Industry & Manufacturing
      • Telecomm­unications
      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications


      • View All Telecomm­unications
  • Lifestyle & Health
      • Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys


      • View All Consumer Products & Retail
      • Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • View All Entertain­ment & Media
      • Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine


      • View All Health
      • Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories


      • View All Sports
      • Travel
      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry


      • View All Travel
  • Policy & Public Interest
      • Policy & Public Interest
      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety


      • View All Policy & Public Interest
  • People & Culture
      • People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women


      • View All People & Culture
  • Overview
  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Worldwide Offices
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO

      Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • News in Focus
    • Browse News Releases
    • Regulatory News
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Policy & Public Interest
    • Policy & Public Interest
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • People & Culture
    • People & Culture
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • Overview
  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Worldwide Offices
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR

ALK Announces FDA Approval for its House Dust Mite Sublingual Allergy Immunotherapy Tablet (ACARIZAX® in Europe)


News provided by

ALK

01 Mar, 2017, 23:36 GMT

Share this article


ALK (PRNewsFoto/ALK)
ALK (PRNewsFoto/ALK)

HØRSHOLM, Denmark, March 1, 2017 /PRNewswire/ --

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet.

     (Logo: http://photos.prnewswire.com/prnh/20160420/357628LOGO )

The HDM SLIT-tablet is an allergen extract and, in the USA, it is indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. The HDM SLIT-tablet is approved for use in adults 18 through 65 years of age. The HDM SLIT-tablet is marketed in Europe and Australia under the brand name ACARIZAX® and in Japan as MITICURE[TM].

The BLA for the HDM SLIT-tablet was originally submitted by MSD (known as Merck in the USA and Canada) in February 2016 under a partnership agreement with ALK. Since then, the partnership has ended and all North American rights to the SLIT-tablet portfolio have been repatriated to ALK following a six-month, managed handover between the two companies.

Carsten Hellmann, President and CEO of ALK, said: "The approval of the HDM SLIT-tablet marks the beginning of a new era for ALK in the USA as we now take full control of the SLIT-tablet portfolio and integrate it into our existing US business. The coming months will see a scaling up of our US organisation so that we can market the already launched GRASTEK® and RAGWITEK®, and build our competences and launch readiness ahead of the introduction of the HDM SLIT-tablet in the USA."

ALK's SLIT-tablets against grass pollen allergy (GRASTEK®) and ragweed pollen allergy (RAGWITEK®) were both approved by the FDA in 2014.

The approval of the HDM SLIT-tablet is not expected to have an impact on ALK's 2017 financial outlook.

ALK-Abelló A/S

About the HDM SLIT-tablet
In the USA, ALK's HDM SLIT-tablet is approved as an allergen extract indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. The HDM SLIT-tablet is approved for use in adults 18 through 65 years of age. In Europe, where it is sold as ACARIZAX®, the product has been approved in 14 countries. It is also approved in Japan where it is licensed by ALK to Torii and marketed under the trade name MITICURE[TM] and in Australia where it is licensed by ALK to Seqirus. The product is also being developed for a number of other markets around the world including Canada, Russia, South-East Asia, Turkey, the Middle East and New Zealand. Altogether, clinical development activities for the HDM SLIT-tablet have involved more than 6,000 patients worldwide.

About ALK 

ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy - a treatment of the underlying cause of allergy. The company has approximately 2,300 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. Find more information at http://www.alk.net. 

SOURCE ALK

Modal title

    Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT

    • General Enquiries
    • Media Enquiries
    • Partnerships
    • Worldwide Offices

    Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

    About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers

    • Asia
    • Brazil
    • Canada
    • Czech
    • Denmark
    • Finland
    • France
    • Germany
    • India
    • Israel
    • Mexico
    • Middle East
    • Netherlands
    • Norway
    • Poland
    • Portugal
    • Russia
    • Slovakia
    • Spain
    • Sweden
    • United States

    My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists

Contact PR Newswire


Products


About


My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2021 PR Newswire Europe Limited. All Rights Reserved. A Cision company.