Liver & Hepatic

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.  

Gilead will make the case that Livdelzi is a better treatment option than Ocaliva or recently approved Iqirvo due to its ability to alleviate pruritus and reduce ALP levels.

Nine new entries targeting a wide range of unmet medical needs. Several EU marketing approvals and two withdrawals. And an accelerated assessment tool that was seldom used. These were among the activities noted as part of the European Medicines Agency’s priority medicines scheme during the first half of 2024.

Despite a share price decline, Madrigal CEO Bill Sibold tells Scrip he is confident that Rezdiffra is off to a strong launch, backed by promising metrics and a solid strategy.

After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.    

The first approved NASH drug topped revenue expectations during its initial quarter on the market, but Madrigal’s share price declined by 12%.

A stacked user fee goal lineup sets the stage for market showdowns in primary biliary cholangitis and IgA nephropathy, the first psychedelic approval decision, and lots of targeted cancer therapies.

Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.

Eisai/Biogen could this week learn whether the European Medicines Agency will give the thumbs up to market lecanemab across the EU for early Alzheimer’s disease.

Several factors are delaying fulfillment of MASH prescriptions, but payers are not holding out for biopsy disease confirmation. KOLs cited by Leerink also call tirzepatide the clear standout in obesity, though access issues are still an issue.

The accelerated approval of Rezdiffra, the first drug authorized by the FDA to treat metabolic dysfunction-associated steatohepatitis (MASH), presents a large opportunity for imaging and diagnostic devices.

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

Akero is developing weekly injectable efruxifermin for MASH with solid 96-week efficacy data and three Phase III studies underway. But will it find a treatment niche in a competitive space?

Iqirvo gains accelerated approval, but Gilead’s seladelpar is probably only two months behind.    

While injectables have had all the limelight, some analysts see a bright future for Sagimet’s oral denifanstat, potentially as a backbone therapy in combination with other treatments for MASH.

Viking will look to plan a Phase III program with the FDA after showing 52-week success on MASH resolution and fibrosis reduction with VK2809. The firm still hopes to move forward with a partner.

UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.    

Cash-limited Organovo has an FXR agonist showing competitive efficacy and tolerability in MASH, but may need a partner to move forward in that disease as it may be prioritizing its IBD program.

Still a clinical-stage company, Viking is studying promising candidates for both obesity and MASH in Phase II, but may need to prioritize one while partnering the other.

Esepapogene zalarnarepvec, BJT-778 and pegozafermin are the latest investigational products that the European Medicines Agency said merited a place on its priority medicines scheme.