Flutiform fluticasone/formoterol regulatory update
SkyePharma and Kyorin said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Flutiform fluticasone/formoterol to treat bronchial asthma in patients aged >=16 years who require combination therapy with inhaled corticosteroids plus inhaled, long-acting adrenergic receptor beta 2 agonists (LABAs). The approval triggered an undisclosed "several million dollar" milestone payment to SkyePharma from Kyorin, which has Japanese rights from SkyePharma. Kyorin plans to launch the product in Japan "as soon as possible" once pricing and reimbursement have been finalized. The product is a fixed-dose combination of formoterol, a LABA, and fluticasone, an inhaled corticosteroid, delivered via a hydrofluoroalkane metered-dose inhaler (HFA-MDI). ...