Off-label marketing has another legal stamp of approval, thanks to Amarin and its feisty pushback against the FDA. The Ireland-based pharma has been fighting for more than a year to promote its fish oil-derived pill for broader use, and it can now do so, even without FDA approval. And thanks to Amarin's legal maneuvering--and savvy choice of jurisdiction--any other drugmaker with truth on its side might soon do the same.
Amarin styled its lawsuit against the FDA looking to lift the restrictions in place on its marketing case for the prescription-strength fish oil Vascepa as a First Amendment issue regarding free speech.
Irish drugmaker Amarin, which reported another quarterly loss today, has sued the FDA for curtailing its free speech, namely being able to discuss off-label uses of its omega-3 capsule Vascepa that might spur some sales.
China's Eddingpharm has been granted rights by Amarin to sell hypertriglyceridemia drug Vascepa icosapent ethyl in Greater China.
Amarin and its omega-3 pill have struck out with the FDA again. The Irish company said today that the agency has again turned down its appeal to reconsider its clinical data it hoped would help it win a label extension for Vascepa, dealing a new blow to its efforts and its financial well being. This FDA first rejected Amarin's request in January.
The market for Omega 3-based prescription drugs was just a one-drug wonder. But now, there are not only two more fish-oil-based brands--Amarin's Vascepa and AstraZeneca's Epanova--but a generic version of Lovaza, too. And all four are looking for their share of a market that is still more potential than actual.
Watch out, GlaxoSmithKline--and Amarin. Teva Pharmaceutical Industries has launched its generic version of Glaxo's fish-oil pill, Lovaza, designed to lower triglyceride levels in patients with cardiovascular disease.
It hasn't been easy being Amarin over the last several months. The Irish drugmaker slammed into one obstacle after another. Read more from FiercePharmaMarketing >>
After a rough go with the FDA sent its shares spiraling downward, Amarin has at last found a partner to help commercialize its fish-oil-derived pill for high triglycerides.
It hasn't been easy being Amarin over the last several months. The Irish drugmaker slammed into one obstacle after another. New chemical entity status for the key ingredient in its cardiovascular drug Vascepa? No, says the FDA. Permission to market the drug to vast numbers of new patients? No again.