The pressure of Eli Lilly’s looming patent cliff has beenreduced after a US Committee has recommended expanding the pain indication forits top selling drug Cymbalta (duloxetine HCL).
The US Food and Drug Administration Anesthetic and LifeSupport Drugs Advisory Committee voted 8-6 in favour of expanding the painindication for the drug. However, the broader pain population is yet to bedefined by the FDA if it does approve this. Cymbalta is currently approved to treatmajor depressive disorder and generalised anxiety disorder and to managediabetic peripheral neuropathic pain and fibromyalgia.
The Committee reviewed efficacy and safety data from threenew Cymbalta studies in chronic low back pain and two new studies in chronicpain due to osteoarthritis of the knee. In split votes for the differentindications, most panellists were supportive of the evidence for chronic lowback pain but not osteoarthritic pain. The committee also voted there wasinsufficient evidence of significant additional efficacy of 120mg compared with60mg in these conditions.
In addition, the Committee voted positively regarding theoverall safety profile of Cymbalta, including potential liver toxicity, withthe majority agreeing that the risk/benefit profile warrants an expandedindication.
Meanwhile, the Committee has also called for larger trialsthat follow patients for longer than 13 weeks, as was used in the studies forthis submission.
Cymbalta made up 14% of Eli Lilly’s revenue last year withthe drug generating $3.07 billion in sales. Patent protection is due to expirein 2013.
According to Leerink Swann & Co analyst SeamusFernandez, Cymbalta could make more than $500 million extra in annual salesshould the FDA approve the drug for the expanded indication.