FDA approves ALK's application for dust mite allergy tablet
Known as the HDM SLIT-tablet, the allergen extract is marketed internationally, in Europe and Australia by the name of ACARIZAX and in Japan as MITICURETM.
In the North American markets, the BLA for the tablet was submitted by MCD (Merck) in February 2016 in a partnership agreement with ALK.
The medication is specially suited to address house dust mite (HDM)-induced rhinitis, whether that is with conjunctivitis or not.
"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," ALK CEO Carsten Hellmann said.
Though the tablet has been approved, it is not likely that it will affect the company's financial prospects in 2017.