Replies to post #432021 on Amarin Corp Plc (AMRN)

[Whalatane]

N7. I thought your view was the Co is not going to proceed with the " condensed " version of Vascepa ...the " condensed " version being the same active ingredient in smaller pill form ..or fewer pills ...to get around the generics and increase patient ease of use and compliance.

The whole reason OLC was developed was for dialysis patients to better control their serum phosphorus levels .
The current pills they take are usually large , numerous and often have to be chewed instead of swallowed ....so poor patient compliance and roughly 300, 000 of the over 400,000 US patients on dialysis are not near the serum pho levels required.

The CV population eligible for a new version of Vascepa would far larger than the CKD dialysis population ...so expect extra scrutiny by the FDA .
In the case of OLC and its limited target population

The FDA required safety data on Unicycive's version of Fosrenol, called Oxylanthanum Carbonate (OLC), for several reasons:

To ensure comparable safety profile: The FDA wanted to confirm that OLC's safety was similar enough to the established safety profile of Fosrenol (lanthanum carbonate)2. This is a standard requirement when a company seeks approval for a new formulation of an existing drug.

Evaluation of gastrointestinal adverse events: Fosrenol is known to cause gastrointestinal side effects, and the FDA wanted to assess whether OLC had a similar or different incidence of these events14. This was particularly important because initial data suggested that OLC might have a higher incidence of gastrointestinal adverse events compared to Fosrenol chewable tablets2.

Tolerability assessment: The FDA agreed with Unicycive's study design to evaluate the tolerability of OLC in 60 participants over 4 weeks, focusing on the event rate for discontinuation3. This data would help determine if patients could tolerate OLC at clinically effective doses.
Comprehensive data package: As part of the 505(b)(2) regulatory pathway that Unicycive is using for OLC approval, the FDA required a complete data package including clinical data, preclinical data, and chemistry, manufacturing, and controls (CMC) information39.

Supplementing existing data: While Unicycive had already conducted bioequivalence studies in healthy volunteers, the FDA requested additional clinical data in patients to proceed with the filing3. This would provide a more comprehensive understanding of OLC's safety profile in the target patient population.. ( my emphasis )

By requiring this safety data, the FDA aims to ensure that OLC meets the necessary safety standards before considering its approval as a new formulation of lanthanum carbonate for the treatment of hyperphosphatemia in end-stage renal disease patients.

Kiwi