Regulators in the USA have cancelled a meeting to review a proposed new indication for Eli Lilly’s blockbuster antidepressant Cymbalta.

The US Food and Drug Administration’s Anesthetic and Life Support Drugs Advisory Committee was due to sit on January 29 to consider whether Cymbalta (duloxetine) should be recommended for approval for the treatment of chronic pain. However the agency now says that the meeting has been cancelled to allow time to review “new information that is relevant to the benefit risk balance for the proposed new indication".

Through a notice on its website, the FDA added that it intends to “continue evaluating the application and, as needed, will announce future meeting dates". Cymbalta, which is already approved for depression, anxiety, diabetic nerve pain and fibromyalgia, had third-quarter sales of $790.2 million, up 10%.
The company withdrew its supplemental New Drug Application for Cymbalta for chronic pain in November 2008 and resubmitted the file in June 2009.

Effient cost effective compared to Plavix
Meantime, Lilly and partner Daiichi Sankyo have published data showing that their clot drug Effient (prasugrel) is cost-effective compared with Sanofi-Aventis/Bristol-Myers Squibb’s Plavix (clopidogrel) “and in most cases cost saving”.

The claim is based on a health economic substudy of the TRITON-TIMI 38 clinical trial involving 6,705 patients. The analysis demonstrates that treatment with Effient compared with Plavix reduced total hospitalisation costs over 15 months, not including the cost of study drugs, by $530 per patient.

The study also revealed that, including cost of the active study drugs as well as costs associated with the initial and subsequent hospitalisations, treatment with prasugrel compared with clopidogrel “decreased cumulative medical costs” by $221 per patient over the length of the analysis.

The companies noted that the study drug costs used in the analysis were the net wholesale price as of August 2009, ie $5.45 per day for Effient and $4.62 per day for clopidogrel. The analysis also compared Effient to generic clopidogrel (Plavix goes off-patent next year) at a hypothetical cost of $1 per day and showed that treatment with Effient “in the subpopulation as a whole was economically dominant during the first 30 days of treatment. After day 31, “although not cost-saving, it continued to be a cost-effective therapy relative to many other accepted medical interventions”.

Effient is approved for the reduction of thrombotic cardiovascular events in patients with acute coronary syndromes who are managed with percutaneous coronary intervention.