Regulators cancel Lilly review

Eli Lilly

US regulators have reportedly cancelled a review meeting set to decide upon proposed new indication for Eli Lilly's blockbuster antidepressant Cymbalta, according to their website.

According to a notice on their website, the US Food and Drug Administration (FDA) has now cancelled the review meeting that was due to take place on 29 January in light of "new information", in hope that a delay in hosting the review will allow such new information to prove to be relevant to the benefit risk balance for the proposed new indication.

Evaluation

However, the FDA also maintains that it intends to "continue evaluating the application" and is likely to announce future meeting dates for the FDA's Anesthetic and Life Support Drugs Advisory Committee to reconvene and consider whether Cymbalta (duloxetine) should be recommended for approval for the treatment of chronic pain.

The drug is already approved for depression, anxiety, diabetic nerve pain and fibromyalgia, and had third-quarter sales of $790.2 million, up 10 percent.

However, the company had already withdrawn its supplemental New Drug Application for Cymbalta for chronic pain in November 2008, sparking concern over the FDA's ruling. Eli Lilly resubmitted the file in June 2009.

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