Intercept Pharmaceuticals Inc (NASDAQ:ICPT), a biotech stocks has announced securing approval for its Ocaliva (obeticholic acid) from the National Institute for Health and Care Excellence (NICE). Ocaliva will be routinely used in England, Northern Ireland and Wales by the National Health Service (NHS).
The drug has been approved for treatment of primary biliary cholangitis (PBC) in the European Union. The drug is used complementarily with ursodeoxycholic acid (UDCA). The drug will be available after 90 day from the final review publication. Intercept will work with local authorities to ensure the drug is accessed by eligible patients.
Although it is not a common disease, PBC is a major cause of liver transplantation among women in the UK. Ocaliva is a new and alternative option for PBC patients who are intolerant to or do not respond to conventional treatment and are at risk of developing full cirrhosis.
Ocaliva is a selective agonist of farnesoid X receptor (FXR). FXR is manifested in intestines and the liver and is a key regulator of bile acid, fibrotic, inflammatory and metabolic pathways. The drug was granted conditional marketing and commercialization permission in Europe based on safety and efficacy from three randomized clinical trials. The clinical trials examined Ocaliva’s effect on bilirubin and alkaline phosphatase (ALP) in people with PBC. The authorization was also based on two clinical information that included over 10,000 patients drawn from the UK-PBC Group and the Global PBC Study Group.
The trial reported two major side effects: pruritus reported in 63% of the patients examined and fatigue reported in 22% of the patients. Adverse side effects leading to discontinuation accounted for 11% in Ocaliva 10 mg arm and 1% in Ocaliva titration arm. The most common cause of discontinuation was pruritus with a majority occurring in the first month of the treatment.
Intercept Lisa Bright said NICE’S fast approval of the drug is affirms the company’s scientific reinvention and value addition as well as cost-effectiveness of Ocaliva. She adds that the decision will enable patients to easily access the treatment. Intercept is one of the top biotech stocks listed at sec.