28th January 2010 was supposed to be a red letter day for Eli Lilly’s Cymbalta. The US FDA was to review the drug company’s application for promoting Cymbalta as a chronic pain reliever for aches caused by osteoarthritis, as well as for lower back pain.
The drug is already the second highest seller as an anti-depressant, anti-anxiety, diabetic nerve pain and fibromyalgia pain reliever. However, the US Health officials have postponed the meeting saying it will, “allow time for the FDA to review new information that is relevant to the benefit risk balance for the proposed new indication. The agency intends to continue evaluating the application and, as needed, will announce future meeting dates”.
It is a known fact that the FDA panel usually obtains more information from outside experts before giving its approval. Eli Lilly had earlier withdrawn an application when its methodology and trials were questioned. Now, it has submitted a fresh application based on its new efficacy/safety study. The company’s patents on its best sellers – the anti-psychotic drug - Zyprexa and Cymbalta are due to expire in the next few years.
The delay in the review may have been the probable cause for a drop of 82 cents in its share price, now valued at $35. The company remained unavailable for comments.