Stallergenes Greer took a big step toward providing its sublingual house dust mite immunotherapy tablet to the European market. The positive outcome of the decentralized registration procedure sets Stallergenes Greer up to challenge ALK for the European market.
London-based Stallergenes Greer delivered phase 3 data on its oral house dust mite immunotherapy late in 2018 before going on to seek approval in Europe via the decentralized procedure 13 months ago. Stallergenes Greer revealed the positive outcome of the procedure, which saw Germany’s Paul-Ehrlich-Institut act as reference member state for 21 European countries, this week.
“Stallergenes Greer’s sublingual allergen immunotherapy tablet is an important option for people suffering from house dust mite-induced allergic rhinitis or rhinoconjunctivitis and illustrates our engagement to provide patients with a range of administration modes tailored to individual needs and profiles,” Stallergenes Greer CEO Michele Antonelli said in a statement.
The approval of the sublingual tablet, which is already available in Australia, Japan, New Zealand and South Korea, advances Stallergenes Greer’s ambitions to provide patients with a range of delivery options. Stallergenes Greer’s portfolio also features oral liquid products and subcutaneous formulations.
Rivals are targeting the same opportunities. ALK brought its sublingual house dust mite immunotherapy to the European market in 2015. Sublingual formulations are designed to provide a convenient way for people to build up tolerance to an allergan. A tablet containing a tiny amount of the allergan is placed under the tongue each day to reprogram the immune system.
Stallergenes Greer already provides a sublingual grass allergy treatment in Europe under the Oralair brand. Oralair is designed to help people with grass allergies build up tolerance against five types of pollen that can cause allergic rhinitis.