Danish-based pharmaceutical company ALK’s European regulatory filing for its ragweed sublingual allergy immunotherapy (SLIT) tablet has received acceptance from the relevant health authorities.
The filing has been accepted through the decentralised procedure, with Germany as the reference member state.
SLIT tablet is used to treat adult patients aged between 18 and 65 with ragweed allergic rhinitis and / or conjunctivitis, despite the use of symptom-relieving medication.
ALK president and CEO Carsten Hellmann said: “Today’s news represents another step forward in globalising our SLIT-tablet portfolio.
“Subject to approval, the introduction of the ragweed SLIT-tablet will be a useful addition to our European product range. In particular, strengthening our expansion markets in Eastern Europe, where ragweed allergy is most common.”
The data used by ALK in the filing is drawn from the North American development programme, which resulted in registrations within Canada and the US.
As part of the programme, 2,517 participants were involved across five clinical trials conducted in North America, Hungary, Ukraine and Russia.
The European regulatory review process is expected to take approximately one year, following which the first market introductions will take place at the beginning of next year.
ALK’s ragweed SLIT-tablet was initially developed for the markets in North America as part of the partnership between ALK and MSD, which is now terminated.
The product was launched in the US and Canada in 2014 under the brand name Ragwitek after completing a clinical development programme and receiving subsequent regulatory approvals.