Astra Gets US "Approvable" Letter For Pulmicort Turbo

Swedish drugmaker Astra has received an approvable letter from the US Food and Drug Administration for its breath-activated dry-powder corticosteroid inhaler Pulmicort (budesonide). The product will be marketed by Astra's wholly-owned subsidiary, Astra USA Inc, when final approval comes through. Only a few routine questions have still to be addressed, and Astra says it is working with the FDA on these.

According to the company, Pulmicort is the largest-selling antiasthma drug in Europe, where it has benefited from the recognition of asthma as an inflammatory condition of the airways. In the USA, however, use of anti-inflammatory asthma agents is very low, with the US market for corticosteroid treatments valued at $250-$300 million a year. This could be expanded to as much as $2 billion a year if the same level of use of these products could be achieved as is the case in the UK, where they have a 55% market share.

Competition With Glaxo Wellcome Products When Pulmicort is introduced in the USA, it will face strong competition from Glaxo Wellcome products, which thus far have dominated the market there. GW's US respiratory products sales in 1995 amounted to L436 million ($673.2 million), up 34% on the previous year. GW's stake in the asthma sector was increased with the launch of Serevent (salmeterol), and a new product, Flovent (also known as Flixotide; fluticasone), which is now being introduced in the USA.