Eli Lilly has seen a slight downturn in its share price on news that labeling for its new antidepressant, Cymbalta (duloxetine), has been revised to include reports of liver injury amongst patients who already have pre-existing disease.
The label now cautions physicians against using Cymbalta – which reaped some $161 million for the company during the second quarter of this year – in patients with chronic liver disease. The drug already carries a warning that it should not be used in patients who drink substantial amounts of alcohol.
Cymbalta was the much-anticipated follow-up to Lilly’s Prozac (fluoxetine), which generated billions of dollars in its prime but was cut short after the earlier than expected loss of a principal patent in the USA. However, Cymbalta’s route to approval was not an easy one, with an approvable letter in 2002 and a second in 2003, followed by a deadline extension as the US Food and Drug Administration took additional time to consider paediatric data [[17/09/02a]], [[02/10/03a]], [[25/06/04c]].
Since its approval in August last year [[05/08/04b]], Cymbalta has found itself under the spotlight again, as have the entire class of SSRI antidepressants: in July, the FDA issued its second warning about a link between antidepressants and suicidal behaviour in adolescents and said it was extending its review to adults using the drugs [[04/07/05b]]. In addition, the agency has said that although controlled trials of Cymbalta in depression and diabetic neuropathic pain did not throw up an increased rate of suicidality, it is investigating a higher than expected rate of suicide attempts in clinical trials of Cymbalta in women with stress urinary incontinence [[04/07/05b]]. Lilly and partner Boehringer Ingelheim pulled the US filing for stress incontinence in January after regulators said they could not approve the product on the data package submitted [[31/01/05b]], although it is approved for this use in many other countries around the world.
Meanwhile, the company says that one of its directors, Sir John Rose, is to leave the board to concentrate on his role as chief executive of Rolls Royce. His elected replacement is J Erik Fyrwalk, group vice-president of agriculture and nutrition, DuPont, and his appointment takes effect on November 1.