Cymbalta gets support for broader use

The pressure of Eli Lilly’s looming patent cliff has been reduced after a US Committee has recommended expanding the pain indication for its top selling drug Cymbalta (duloxetine HCL).

The US Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee voted 8-6 in favour of expanding the pain indication for the drug. However, the broader pain population is yet to be defined by the FDA if it does approve this. Cymbalta is currently approved to treat major depressive disorder and generalised anxiety disorder and to manage diabetic peripheral neuropathic pain and fibromyalgia. 

The Committee reviewed efficacy and safety data from three new Cymbalta studies in chronic low back pain and two new studies in chronic pain due to osteoarthritis of the knee. In split votes for the different indications, most panellists were supportive of the evidence for chronic low back pain but not osteoarthritic pain. The committee also voted there was insufficient evidence of significant additional efficacy of 120mg compared with 60mg in these conditions.

In addition, the Committee voted positively regarding the overall safety profile of Cymbalta, including potential liver toxicity, with the majority agreeing that the risk/benefit profile warrants an expanded indication.

Meanwhile, the Committee has also called for larger trials that follow patients for longer than 13 weeks, as was used in the studies for this submission.

Cymbalta made up 14% of Eli Lilly’s revenue last year with the drug generating $3.07 billion in sales. Patent protection is due to expire in 2013.

According to Leerink Swann & Co analyst Seamus Fernandez, Cymbalta could make more than $500 million extra in annual sales should the FDA approve the drug for the expanded indication.