Merck ($MRK) has taken a step closer to an NDA for its new allergy pill. Data from a Phase III study of 565 adults who suffer from ragweed allergies showed a significant level of relief for subjects, compared with what they could gain from a placebo.
The trial participants received one of two doses of the allergy pill--which relies on Ambrosia artemisifolia, the chemical name of the ragweed allergen that is linked to seasonal misery for many people--over a course of 52 weeks. Investigators tracked nasal and eye symptoms familiar to anyone with allergies, recording a 27% and 21% drop in symptoms versus the placebo arm. And they say the data is good enough to file for an approval in 2013.
"Immune therapy actually modifies the disease. It educates the immune system to get rid of allergic responder cells, and to become tolerant of allergens," said Rupert Vessey, head of respiratory and immunology research at Merck, as quoted by Reuters.
"Merck has partnered with ALK-Abello to develop AITs to treat these allergens in North America and plans to file new drug applications for its ragweed and grass AITs with the U.S. Food and Drug Administration in 2013," the company noted in a statement about the late-stage results.
- here's Merck's release
- get the Reuters story