Replies to post #413884 on Amarin Corp Plc (AMRN)

[Whalatane]

Zip / RMB I wish it was that easy but doubt that it is ....if it was, AMRN probably would have done it long ago .
FDA will want more info
You are replacing the daily dose from being spread half in the am and half in the pm .....with a once a day dose ?
I'm not clear on this so correct if necessary .
Are we talking about 1 pill once a day to deliver the EPA equivalent of 4 gms of Vascepa ( 2 gms in the am and 2 gms in the pm ) .....OR one pill / capsule in the am and one in the pm ?

The recent history of UNCY might be instructive .
UNCY is trying a similar thing with phosphate binders for dialysis patients ...to reduce the pill burden .
Fewer pills better chance of patient compliance
The new pills are bioequivalent .....just a concentrated version of the original .
FDA's response

As previously noted, the Agency had requested a 6-month toxicity study in mice comparing LDC and lanthanum carbonate (LC), the drug substance in Fosrenol®, the Reference Listed Drug for the 505(b)(2) regulatory pathway. The study report was submitted to the Agency as part of the pre-NDA meeting package showing that there was no evidence of any gastrointestinal (GI) neoplasms for either LC- or LDC-dosed mice. However, upon review of the study report, the Agency pointed out that although the GI adverse findings observed with LDC are qualitatively similar to lanthanum carbonate, there were quantitative differences.

Based on the review of this information, the FDA has asked the Company to provide additional information, including risk assessment and clinical data, to evaluate the tolerability of LDC in patients with chronic kidney disease on dialysis. The Company requested a follow-up meeting with the FDA to discuss its additional requests.

“We will work diligently to gain alignment with the FDA on the additional data requirements and plan to provide further updates regarding the program in the third quarter of this year,” stated Shalabh Gupta, MD, CEO of Unicycive. “We remain undeterred in our enthusiasm for the potential best-in-class profile of LDC and are dedicated to bringing this important new treatment option to patients as soon as possible.”

Unicycive is seeking FDA approval of LDC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between LDC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of lanthanum dioxycarbonate to Fosrenol was established.

So FDA will want data on if the degree of adverse events is more or equal to Vascepa 4 gms a day ...since the dosing will change ...even if the drugs are pharmacodynamic bio equivalent

JMO
Kiwi