Sector News

New analysis encourages Intercept to refile NASH drug for approval

July 14, 2022
Life sciences

A drug being tested against a liver disease thought to affect millions of people continues to hold up in a large clinical trial, according to its developer, New Jersey-based Intercept Pharmaceuticals.

The trial has enrolled thousands of patients with nonalcoholic steatohepatitis, or NASH, a disease characterized by a buildup of fat in the liver that progressively scars the organ. NASH is often asymptomatic until later stages, making it more difficult to diagnose. Yet, this “silent” disease has become one of the leading causes for liver transplants in the U.S.

Drug companies large and small have been spent more than a decade trying to develop the first approved treatment for NASH. In that race, Intercept and its candidate, known as obeticholic acid or OCA for short, have held a leading position.

In early 2019, OCA became the first drug to succeed in a Phase 3 study of NASH patients. The trial, named REGENERATE, enrolled participants with moderate to severe liver scarring, and found that a significantly greater percentage of those given a high dose of Intercept’s drug — as opposed to a placebo — had their liver scarring improve without their NASH getting worse. READ MORE

By Jacob Bell

Source: biopharmadive.com

comments closed

Related News

May 26, 2024

From pharma to food: Vitafoods 2024 highlights

Life sciences

Beyond the vibrant displays and insightful discussions at Vitafoods 2024 stood the backdrop of a rapidly expanding nutraceutical market. With consumers increasingly seeking preventive healthcare solutions and natural alternatives to traditional medicine, the global nutraceutical industry has witnessed remarkable growth in recent years.

May 26, 2024

Genmab completes acquisition of ProfoundBio

Life sciences

Genmab has completed its $1.8 billion acquisition of ProfoundBio, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADC)s and ADC technologies for the treatment of cancers.

May 26, 2024

Merck to acquire life science company Mirus Bio

Life sciences

Merck has agreed to acquire US life sciences company Mirus Bio for $600 million (around €550 million) from Gamma Biosciences, a life sciences platform established by global investment firm KKR. Based in Madison, Wisconsin, Mirus Bio is a specialist in the development and commercialization of transfection reagents.

How can we help you?

We're easy to reach