Intercept Pharma (ICPT) Briefing Docs Raise New Questions, But All Appear Addressable - Leerink
Leerink affirms Intercept Pharma (Nasdaq: ICPT) at Market Perform with a price target of $144 as OCA briefing docs were posted ahead of an FDA panel this week.
ANalyst Joseph Schwartz commented, the FDA briefing documents for obeticholic acid (OCA) were released this morning and are largely in line with our recently-outlined expectations (LINK) and we maintain our opinion that ICPT is likely to receive a positive panel vote on Thursday, 4/7, and secure approval in the primary biliary cholangitis (PBC) indication by the revised PDUFA date of 5/29.
Schwartz elaborated:
- As we expected, the FDA is focused on ICPT's choice of surrogate endpoint and OCA seems to pass the FDA's sensitivity analyses using different thresholds for response. However, the FDA notes that they recommended against using just one biomarker for response and the fact that 92% of patients were enrolled with normal bilirubin means that the primary endpoint for the POISE trial evaluated in essence changes in only 2 of the 3 criteria, both related to changes in the same biomarker (alkaline phosphatase). The FDA notes that the results apply only to a milder population of PBC patients. This could lead to some interesting discussion since OCA's is intended for use in patients refractory to the current standard of care ursodiol.
- FDA puts a significant emphasis on the appropriate use of OCA in patients with liver impairment. It is surprising that the FDA's main safety concern appears to be liver safety rather than pruritis or LDL increases, although these issues may be linked, due to 4-17x higher exposure in patients with liver impairment. There is no mention of the need to consider a black box warning in the briefing documents. However, the FDA points out that ICPT considered many liver-related serious adverse events (SAE) as not related to OCA, where a causal relation with OCA cannot be ruled out. FDA notes that OCA caused liver injury at higher exposures in nonclinical/early studies and exposures are higher in patients with underlying liver disease.
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