According to the EMA, its Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion regarding the Labazenit budesonide/salmeterol dry powder inhaler. Belgian pharmaceutical company Laboratoires SMB applied to market the product, which is delivered using its Axahaler DPI device, for the treatment of asthma in adults.
The CHMP expressed concerns “the study comparing Labazenit with budesonide alone did not prove that the anti-inflammatory effect of Labazenit was sufficient.” Lower deposition of budesonide in the lungs was also cited as a concern.
SMB’s Axahaler is a capsule-based, breath-activated device. The company’s website boasts that its dry powder formulations “can provide higher drug deposition than the reference products.” SMB currently markets a formoterol fumarate DPI under the brand name Formagal and a fluticasone propionate DPI under the brand name Flutaxa.
Read the EMA opinion.
