FDA has recently approved a new drug treatment produced by Intercept Pharmaceuticals Inc., a product which will treat primary biliary cirrhosis, a slow-progressing liver disease.
The drug was approved by the Food and Drug Administration with the condition that the company’s researchers will continue the study to prove that this treatment will reduce the risk of death and liver transplant as this is the first product that will be promoted on the U.S. market.
The National Institutes of Health established that primary biliary cirrhosis is very rare and usually affects women between 30 and 60 years old. Furthermore, this disease affects the ducts that carry bile, a digestive fluid. With no treatment, it might lead to severe consequences, such as liver failure and cirrhosis.
This drug may also treat another liver condition known as nonalcoholic steatohepatitis, or NASH, which is related to a more encountered biliary cirrhosis and obesity. NASH treatments may go up from$5 billion to $10 billion every year, according to Michael Yee, an analyst with RBC Capital Market Corp.
Plus, statistics have shown that Obeticholic acid is expected to reach $1.6 billion in sales by 2020.
Scientists from Intercept initially studied if the drug lowers levels of alkaline phosphatase (ALP), a sign of liver damage. Presently, many patients are attending a thorough study to establish the effect of the drug on the percentage of death and liver failure. According to the National Institutes of Health, the study is expected to finish in 2023.
The reason why FDA’s approval was so important is that this drug was analyzed by many doctors and specialists. They work every day with many drugs and types of disease, making these experts the most qualified.
Plus, it is the first time in 20 years when a drug, such as Ocaliva is approved to deal with PBC. Moreover, the sales are expected to be decent enough to make the drug popular and most importantly useful in hospitals. Therefore, sales are expected to reach at least $5 or $6 billion.
Hopefully, the Intercept’s drug will decrease the death rate and the need of liver transplant. This way people will have more chances of living a healthy life and the medical field will have a wider variety of treatments.