According to a story from sectorpublishingintelligence.co.uk, the drug company INVENTIVA’s lead product candidate, known as lanifibranor, has earned Fast Track Designation from the US Food and Drug Administration (FDA) as a treatment for nonalcoholic steatohepatitis, a potentially serious disease of the liver. There are currently no approved treatments for this disease. The company has recently completed recruitment for a phase 2b clinical trial that will test lanifibranor as a treatment for the disease.
About Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a type of liver disease in which fat is deposited in the liver independent of excessive alcohol consumption. This disease can progress rapidly. Risk factors include metabolic syndrome and insulin resistance. There appears to be some genetic component to the disease as well. This condition also increases the risk of other health problems and liver cancer. Men also seem to be at greater risk, getting the disease as almost twice the rate that women do. Symptoms of nonalcoholic steatohepatitis include jaundice, malaise, fatigue, and abdominal pain or discomfort. Without treatment, the liver can become scarred and the patient may need a liver transplant. However, the condition can also be managed with proper diet, the use of certain medications, and exercise. To learn more about nonalcoholic steatohepatitis, click here.
About Fast Track Designation
The Fast Track designation from the FDA was implemented with the intention of increasing the speed at which an experimental product candidate can be evaluated for official approval. A therapy potentially may qualify for Fast Track designation if it is designed to treat a disease with serious unmet clinical need or to treat a disease that is considered severe or life-threatening. A drug must also display possible benefits over currently available treatments when they are present. Fast Track designation provides several benefits to the recipient company, such as more frequent communication and collaboration with the FDA and the potential to qualify for other incentives such as Priority Review and Accelerated Approval.
About The Clinical Trial
INVENTIVA’s phase 2b clinical trial is expected to run for a 24 week period. The endpoints used in this study will include ballooning and inflammation of the liver. In addition, the progression of fibrosis (liver scarring) will also be monitored during the trial period. The trial will include a total of 247 nonalcoholic steatohepatitis patients.
