US approval for ALK’s house dust mite pill

US regulators have approved Odactra, the first allergen extract to be administered under the tongue to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis) in people 18 through 65 years of age.

House dust mites are the most common cause of allergy in the world, affecting 90 million people in Europe, North America and Japan, and more than 100 million in China. Nearly 50 percent of all house dust mite-allergic rhinitis patients suffer from concomitant asthma.

The HDM sublingual allergy immunotherapy (SLIT) can now be used by doctors to treat the condition, with or without conjunctivitis, when 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 application in the US was originally submitted by MSD (known as Merck in the USA and Canada) in February 2016 under a partnership agreement with ALK. But 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.

"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," noted Carsten Hellmann, president and chief executive of the Danish drugamer.

"The coming months will see a scaling up of our US organisation so that we can market the already launched Grastek and Ragwitek [SLIT tablets against grass and ragweed pollen allergies], and build our competences and launch readiness ahead of the introduction of the HDM SLIT-tablet in the USA."

The HDM SLIT-tablet is already marketed in Europe and Australia under the brand name Acarizax and in Japan as Miticure.