Posted by Michael Wonder on 02 Mar 2017
ALK announces FDA approval for its house dust mite sublingual allergy immunotherapy tablet (Acarizax in Europe)
1 March 2017 - ALK today announced that the US FDA has approved the biologics license application for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet.
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.
