Specialty pharmaceutical company Pharmaxis Ltd has submitted the marketing authorisation application (MAA) for its asthma management product Aridol to the Swedish Medicinal Products Agency (MPA), the national authority responsible for the regulation and surveillance of drugs and other medicinal products in Sweden.

Authorisation can take from six to eighteen months and, if granted, will allow Pharmaxis to sell Aridol in the 25 member countries of the European Union, a company release says.

Alan Robertson, Pharmaxis chief executive officer said: "This European submission is a further important step in the commercialisation of Aridol. Additionally, we have a number of investigator led Aridol clinical studies in progress in Europe. Together with our initiatives in the United States and Australia, this is a key step in making Aridol available worldwide."

Pharmaxis' application is supported by data from Phase II and Phase III studies of Aridol in patients with asthma. More than 600 patients participated in the pivotal Phase III clinical study, which was conducted in Australia and completed in 2004.