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Intercept’s NASH Hopes: A Case Study For Implications Of US Pricing Bill

 
• By Michael McCaughan

Interecept is reviving hopes that it will be able to capture a potential blockbuster indication for its liver disease drug Ocaliva. The development strategy might never happen again if the US drug pricing bill becomes law.

NASH reimbursement
The drug pricing legislation under consideration in Congress could change the development strategy for products targeting liver disease and every other condition. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Intercept Pharmaceuticals, Inc. is ready to try again with a potential blockbuster label expansion for its liver drug obeticholic acid as a treatment for non-alcoholic steatohepatitis (NASH).

Whether the second attempt at approval – the first sNDA for NASH was rejected by the US Food & Drug Administration in 2020 – succeeds is obviously a very big deal

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