Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.
Tag Archive for: liver disease
Viking Therapeutics’ nonalcoholic steatohepatitis candidate VK2809 significantly improved secondary histologic endpoints at 52 weeks with no worsening of fibrosis, as assessed by hepatic biopsy.
Mammoth’s CRISPR-based gene editing platform and Regeneron’s delivery technologies will be used to create disease-modifying medicines that can be delivered to tissues beyond the liver.
The drug was approved under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
Gilead Sciences announced Monday it is acquiring CymaBay Therapeutics and its lead candidate seladelpar, an investigational treatment for primary biliary cholangitis, in a $4.3 billion deal.
The Danish drugmaker said the partnerships with Omega Therapeutics and Cellarity Inc. could lead to new treatments for people living with obesity and a type of liver disease known as MASH.
In a late-stage trial, treatment with Ipsen and Genfit’s elafibranor led to high rates of biochemical response and the normalization of alkaline phosphatase levels compared with placebo.
With this deal, expected to close by the end of the year, Alfasigma aims to expand its treatment portfolio related to liver diseases and digestive system disorders.
In Genethon’s Thursday announcement, the company claimed the results are the first clinical demonstration of the efficacy of gene therapy in a metabolic disease of the liver.
The deal gives Moderna access to Generation Bio’s proprietary drug delivery system and DNA technology to develop drugs targeting immune cells and the liver.