The FDA has dealt a blow to GlaxoSmithKline's hope of extending its Advair Diskus drug to cover chronic obstructive pulmonary disease. Regulators issued a "not approvable" letter, citing the higher Advair dosage proposed to treat COPD, Glaxo said.
The decision was something of a surprise, because the FDA advisory panel in May voted for approval, agreeing that Advair did cut the risk of COPD. The company plans to meet with the FDA about data on side effects in preparation for a new run at approval. Though Advair is already Glaxo's biggest respiratory drug, with $3.3 billion in annual sales, it lags behind Merck's $4 billion blockbuster Singulair.
- see this FierceBiotech report [1]
Links:
[1] http://www.fiercebiotech.com/story/gsk-nixed-advair-application/2007-08-08