Archive for February, 2011

Amarin’s AMR101, a prescription omega-3 fatty acid – is it worth the extra cost?

Posted by lifetech on February 24th, 2011

If approved, Amarin Pharmaceuticals’ AMR101, a synthetic omega-3 fatty acid, will enter a market filled with over-the-counter (OTC) fish oil supplements and Lovaza, a product that will be its only prescription competitor. Thus, Amarin must show that AMR101 not only warrants FDA approval as an effective therapy for elevated triglycerides, but that it also deserves the premium pricing associated with prescription products. Further, data must show competitive advantage vs Lovaza.

AMR101 contains only one omega-3 fatty acid – EPA. This contrasts with Lovaza which contains both DHA and EPA, the two omega-3s typically found in dietary sources of omega-3s (ie, fish), but in a more purified form than the OTC products, which are often simply fish oil extracts. Thus, part of the challenge entails showing that EPA alone is advantageous vs the established profile of available products.

Results from an initial trial (MARINE) that evaluated use of AMR101 in those with very high triglyceride levels (>500 mg/dL) seem favorable. That said, there are several broader issues that may impact FDA’s decision and market acceptance. Among them:

  1. Will results differ for ANCHOR, the second trial designed to support a broader indication in a population with less severe triglyceride increases?
  2. What are the differences in effect between EPA and DHA and will the fact that AMR101 only contains EPA impact its efficacy?
  3. Will AMR101 have the same adverse impact on LDL as Lovaza and thus similarly narrow AMR101’s approved uses? And what about the effects on HDL?
  4. What role do triglycerides play in cardiovascular risk?
  5. What is the evidence that fish oils have a beneficial effect on cardiovascular risk and will AMR101’s distinct profile affect that benefit?
  6. What is driving FDA’s request for initiation of a cardiovascular outcomes trial as a condition of broader approval?
  7. An ultimately – the big question – why a prescription product when an OTC product ‘just might do’?

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