ALK has 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.
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 MITICURETM.
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 chief executive officer 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.