Eli Lilly: FDA nod adds gravitas to fibromyalgia

Jun 17, 2008 (Datamonitor via COMTEX) -- LLY | Quote | Chart | News | PowerRating -- Eli Lilly's Cymbalta has won regulatory backing in the US for the management of fibromyalgia. Following the June 2007 approval of Pfizer's Lyrica, Cymbalta has become only the second approved treatment for a condition that has battled hard to gain legitimacy within the medical world and general public. Cymbalta's commercial success will be short-lived however, with patent expiry expected in 2013.

Cymbalta (duloxetine) is an orally administered dual serotonin and norepinephrine reuptake inhibitor (SNRI). Initially launched in the US in August 2004 for the treatment of major depressive disorder (MDD, EU launch came in February 2005), and approved for stress urinary incontinence in the EU in the same month, Eli Lilly has since gained US and EU approval for diabetic peripheral neuropathic pain (DNP) and generalized anxiety disorder.

Filed in August 2007, the sNDA submission for Cymbalta as a treatment for the management of fibromyalgia was based on data from approximately 1,400 patients in five clinical trials and was subject to a standard 10-month FDA review process, resulting in this positive June 2008 decision.

Mainly affecting women, fibromyalgia syndrome affects six million people in the US alone. This relatively common yet poorly understood syndrome is characterized by widespread chronic musculoskeletal pain and fatigue and remains substantially underserved by the medical profession and the pharmaceutical industry.

With a considerable patient potential and large medical unmet need, the untapped fibromyalgia market represents a lucrative opportunity for pharmaceutical companies. Estimated at around $650m in 2007 in the seven major markets (7MM), Datamonitor forecasts the market to grow to over $2.5 billion in 2017. Extensive direct-to-consumer advertising and the commercial success of new fibromyalgia brands such as Lilly's Cymbalta and Pfizer's Lyrica (pregabalin), will provide a new level of validity for the previously questionable condition and will encourage other companies to consider investment.

Datamonitor expects Cymbalta to receive strong uptake in the fibromyalgia market, with its approval set to build upon a growing historical off-label use of the drug. Lilly's broad experience in the CNS market will also be a key factor when going head-to-head with Pfizer's Lyrica, and Pierre Fabre's/Cypress Bioscience's/Forest's milnacipran.

Cymbalta will be successfully positioned as a first-line treatment option, particularly for female patients suffering from co-morbid depression. In an upcoming fibromyalgia-specific market analysis report, Datamonitor forecasts 7MM Cymbalta sales for fibromyalgia to peak at over $700m in 2012 prior to US and EU patent expiries. The loss of market exclusivity and availability of cheaper generic versions in both regions from 2013 will significantly impact Cymbalta's returns from the fibromyalgia market after this date.

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