Lilly seeks Cymbalta fibromyalgia claim
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly may be able to offer an alternative fibromyalgia treatment to Pfizer's Lyrica (pregabalin) by June 2008 if its sNDA for Cymbalta (duloxetine) is approved within a standard 10-month review. The filing was announced by the company Aug. 21. Cymbalta is approved for treatment of major depressive disorder, management of diabetic peripheral neuropathic pain and treatment of generalized anxiety disorder in adults (1Pharmaceutical Approvals Monthly March 2007, p. 20). Separately, Lilly released clinical trial data for the serotonin-norepinephrine reuptake inhibitor showing greater reductions in pain severity one week after starting treatment compared to placebo. The sNDA is based on data from 1,400 patients across five clinical trials, the firm said. Pfizer has estimated the fibromyalgia indication could add $1 billion in incremental sales for Lyrica...
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.