Date: 2011-11-05
Type of information: Results
phase: 3
Announcement:
Company: Merck&Co (USA) ALK Abello (Denmark)
Product: Ragweed AIT
Action
mechanism: Immunotherapy product Disease:
Therapeutic
area: Allergic diseases - Immune diseases Country:
Trial
details: Latest
news: ALK's partner in North America, Merck&Co has presented data from two pivotal clinical Phase III studies with its investigational sublingual Ragweed Allergy Immunotherapy Tablet (AIT) at the annual meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, USA. Both Phase III studies met the combined primary efficacy endpoint of reducing allergy symptoms and use of concomitant symptom relieving medication and the efficacy results were consistent between the two studies. Merck has presented data showing that patients treated with the highest dose in the two studies experienced a 24% and 27% reduction (p<0.05), respectively, in the combined primary efficacy endpoint. The registration studies also shows that the treatment was well tolerated, with adverse events experienced by subjects receiving the drug similar to previous studies in adults, with no new or unexpected findings. The most commonly reported treatment-related adverse events in both studies were as expected, transient local application site reactions in the throat, ear, and mouth (throat irritation (29% and 21%), ear pruritus (16% and 12%) and oral pruritus (19% and 8%)). The studies were conducted by Merck&Co, ALK's strategic partner in North America. A total of approximately 1,350 subjects were included in the studies.In the clinical development programme to date, two pivotal efficacy and safety studies and two safety studies have been completed for Ragweed AIT. Merck&Co expects to file registration applications with the FDA, in 2013 for Grass AIT and Ragweed AIT.
