Actair (house dust mite allergen desensitization) / Stallergenes, Shionogi - LARVOL DELTA

Safety of Sublingual Immunotherapy: A Secondary Analysis of Post-marketing Adverse Events Reports Using a Japanese Public Database. (PubMed, Cureus) - "Methods We conducted a secondary analysis of adverse events reported in the Pharmaceutical Adverse Events Information Database for three SLIT drugs (Actair®, Cedarcure®, and Miticure®) approved in Japan. Conclusions Our research illuminated the safety of SLIT drugs in Japan, revealing a favorable profile. It underscores the need for vigilance, particularly among younger patients and during initial doses, emphasizing the importance of proper patient selection and further research to enhance the treatment's efficacy."

Adverse events • Journal • P4 data • Allergic Rhinitis • Immunology • Inflammation • Pediatrics

Safety and effectiveness of a 300 IR house dust mite sublingual tablet: descriptive 4-year final analysis of a post-marketing surveillance in Japan. (PubMed, Immunotherapy) - "Patients (n = 16) who discontinued 300 IR HDM tablet due to symptomatic improvement had sustained improvement relative to baseline 1 to 2 years later. Long-term use of the 300 IR HDM tablet is safe and effective."

Journal • P4 data • Allergic Rhinitis • Immunology • Inflammation

Safety and effectiveness of the 300 IR sublingual house dust mite allergen immunotherapy tablet: 2-year interim analysis of a specified drug-use survey. (PubMed, Immunotherapy) - " The HDM tab appears to be safe and effective in real-world conditions during 2 years of continuous use. Trial registration number: University hospital Medical Information Network (UMIN) Clinical Trials Registry identifier: UMIN000042840."

Clinical • Journal • Allergic Rhinitis • Immunology

DSMB1 recommends the discontinuation of VO64.08 study (Actair in children) (Tradingmarkets.com) - P3, N=471; DSMB has recommended the study Actair P3 in children to be discontinued as same efficacy was not demonsatrated in children as in adults; Results of the ongoing large scale allergen chamber study expected in Q2 2012

Discontinued • Asthma