EU recommends approval of antihistamine syrup for infants

EMEA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Aerius (desloratadine) syrup for the relief of symptoms associated with allergic rhinitis (AR) and chronic idiopathic urticaria (CIU) in children between the age of 1 and 2 years.

Schering-Plough Europe's Aerius is currently approved in the EU for AR and CIU in patients 2 years of age and older.

The CHMP recommendation serves as the basis for a European Commission approval. A positive Commission decision would result in market authorisation with unified labelling for Aerius as the first non-sedating antihistamine to be approved throughout the EU for adults and children as young as 1 year. A new expanded dosing range will be valid in the current 25 EU member states, as well as in Iceland and Norway.

Aerius is a highly potent H-1 receptor antagonist that effectively controls seasonal allergic rhinitis (SAR) symptoms with nonsedating relief for 24 hours. In clinical trials, the overall incidence of adverse events in infants and toddlers aged 6 to 23 months, the most frequent adverse event reported in excess of placebo were diarrhoea (3.7%), fever (2.3%) and insomnia (2.3%).

Schering-Plough markets desloratadine under the brand names Aerius and Neoclarityn in Europe and as Clarinex in the US.