Merck & Co has announced that its Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the US Food and Drug Administration.
The treatment, which is a sublingual dissolvable tablet, has been developed in partnership with Danish drugmaker ALK-Abello. The firms also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT earlier this month.
There is much excitement over AITs given that current treatment is administered with injections. Also, the tablets are designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against targeted allergens.
Jeffrey Chodakewitz, interim head of the respiratory and immunology unit at Merck Research Laboratories, said the FDA's acceptance of the BLA is an important milestone. If approved, the grass pollen AIT "would represent a potential new option for allergy specialists to offer appropriate allergic rhinitis patients".
Rival Stallergenes filed Oralair, its five-grass pollen extract AIT sublingual tablet with the FDA in February.