CHMP turns down new indication for Lilly's duloxetine, again
This article was originally published in Scrip
Lilly would have to submit a whole new application to the European Medicines Agency if it wanted to secure a new indication for three of its duloxetine products for treating moderate to severe chronic somatic pain in patients who do not regularly take NSAIDs.
Back in July, agency's scientific committee, the CHMP, issued a negative opinion which Lilly subsequently appealed against. After re-examining its initial opinion the committee was still concerned, and concluded that the product's risks still outweighed its benefits.
Asked what it would do next, Lilly commented that different treatment options were important for patients with chronic low back pain and chronic osteoarthritic pain because responses to medications can be highly individualised. "Although Lilly is disappointed by the CHMP's decision, the company remains confident in the clinical profile of duloxetine. It is not possible to appeal a second negative opinion," said a spokesperson.
An EMA spokesperson said that the company would have to resubmit a new application addressing the issues cited.
The agency claims that the studies presented in Lilly's submission had not proven that duloxetine would provide a benefit relevant to the applied for indication. There was also little evidence that the effect of the drug would be maintained over time, which is important for treating long term conditions. It also wanted more evidence on the effects of the duloxetine in elderly patients and in the product's safety in the intended patients.
Lilly's evidence was based on five main studies in 839 patients with chronic somatic pain. Two studies were conducted in patients with knee pain caused by osteoarthritis and three in patients with chronic low back pain.
The three drugs are licensed to treat pain caused by diabetic peripheral neuropathy. Cymbalta and Xeristar are also used for treating major depression and generalised anxiety disorder. The negative opinion does not affect any of these indications. Lilly declined to comment on how important the new indication was for the firm.
The studies in chronic pain associated with osteoarthritis and chronic low back pain submitted to the agency have led to approvals in 16 countries or territories, said the firm. These include chronic musculoskeletal pain in the US, Argentina, Costa Rica, El Salvador, Ecuador, Guatemala, Honduras, Lebanon, Panama, Pakistan, Peru and Puerto Rico; chronic pain associated with chronic low back pain and osteoarthritis in Brazil, Mexico and Thailand, and chronic low back pain in Canada.
Companies have 15 days to appeal against a CHMP opinion. If a re-examination procedure is granted, two new rapporteurs are appointed and have 60 days to reach a conclusion.