FDA approves S-P's Asmanex Twisthaler

US drug major Schering-Plough says its Asmanex Twisthaler 110mcg (mometasone furoate inhalation powder) has received Food and Drug Administration approval for asthma. Specifically, the agency has cleared the product as both a maintenance therapy and a preventative treatment for patients aged four to 11.

The FDA's decision is based on data from a 12-week placebo-controlled trial in 296 pediatric patients who had been diagnosed as suffering from asthma for at least six months. The results showed that the drug conferred a significant improvement in forced expiratory volume (FEV1), while secondary endpoints, including peak respiratory flow and the need for rescue medication, were also positive.

S-P said that the FDA had first approved a 220mcg formulation of the Asmanex for patients aged 12 and over in 2005 (Marketletters passim). The firm added that clearance for the pediatric population was likely to increase the product's share of the under 18 year old asthma market, currently estimated to be worth $3.2 billion a year.