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Denisk

05/23/25 1:49 PM

#435943 RE: north40000 #435942

Re" FDA Compliance Policy Guide 120.100.". Do you have a link of the website for the Lovaza guidance ?
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Tatsumaki

05/23/25 7:06 PM

#435945 RE: north40000 #435942

TF you even talking about? Lovaza's entire schtick was 15 years ago everyone believed lower trigs = cvd benefit. Dr's Rx'd billions in sales based on that belief. Trigs was an accepted biomarker for cvd at the time.

The Anchor label wasn't going to be a CVD label. The phase 3 was only lower Trigs and that was the label. Still a surrogate indicator for CVD benefit. Vascepa was Lovaza's refinement, a brand replacement for Lovaza that was going generic. Brought to the US by the same crew copying Mochida IP in both cases. The sale pitch was lowers trigs like Lovaza but doenst impact ldl-c like Lovaza so it's much better. It had a target market 10x the size of Lovaza that was selling >$1B a year. It was going to be huge. Reduce It was only run because FDA demanded it be enrolled before granting the Anchor label because they didnt like Jelis focused on high fish Japanese diets.

FDA changed their position on trigs as a surrogate for CVD, pulled the SPA, and that killed the Anchor label and ultimately Amarin. All Amarin had left was Reduce It, so they finished it out and tried to market that as an indication.
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lizzy241

05/24/25 1:53 PM

#435965 RE: north40000 #435942

North, I happen to have a Lovaza capsule. A couple of years ago my neighbor and I were having a conversation about Vascepa after she told me her doc prescribed L for the same indications as V. She was given the generic version of Lovaza, which has APO900 imprinted on the capsule. She couldn't take them cause of the fish taste & burps.