Drugs

Merck's Efinopegdutide Shows MASH Resolution, Fibrosis Improvement

Merck's investigational GLP-1/glucagon receptor dual agonist efinopegdutide (MK-6024) demonstrated higher rates of MASH resolution and liver fibrosis improvement than placebo in a Phase 2b trial involving patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis.

The results, presented at the American Association for the Study of Liver Diseases (AASLD) meeting 11/5, were based on the 381-patient MK-6024-013 trial (NCT05877547), which evaluated three doses of efinopegdutide in adults with biopsy-confirmed MASH and stage F2–F3 fibrosis.

MASH resolution without worsening of fibrosis was achieved by 56%, 63% and 61% of patients receiving efinopegdutide at 4 mg, 7 mg and 10 mg, respectively, compared with 13% of placebo recipients, according to Merck.

Improvement in liver fibrosis of at least one stage was reported in 43%, 52% and 34% of patients in the respective efinopegdutide groups, versus 21% with placebo.

The trial also included an open-label semaglutide comparator arm, in which 53% of patients achieved MASH resolution without worsening fibrosis compared with 13% of the placebo group and 53% for semaglutide. The study was not designed to establish comparative efficacy between efinopegdutide and semaglutide.

The findings suggest that the 7-mg dose may offer a favorable balance of histologic efficacy, producing the highest response rates for both MASH resolution and fibrosis improvement among the three efinopegdutide doses evaluated, according to Merck.

FDA Clarifies Drug Interaction Study Requirements, Labeling Expectations

FDA officials say drug manufacturers may be able to establish dosing recommendations and characterize drug-drug interaction risks without conducting additional clinical studies, including through pharmacokinetic modeling and real-world data, provided the evidence is scientifically justified. During a series of FDA presentations released 11/4 on [Drug Interaction Information

Rybrevant Faspro OK’d in Aggressive Head and Neck Cancer

FDA has granted Janssen Biotech accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) and its use in treating adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. “HNSCC is an aggressive, life-threatening disease

Significantly More Unannounced Foreign Inspections

FDA associate commissioner for inspections and investigations Elizabeth Miller says unannounced drug inspections in China and India increased significantly in FY 2026 compared with FY 2025 inspection numbers. As reported by the Regulatory Affairs Professional Society’s online Regulatory Focus newsletter, she spoke at the Association for Accessible Medicines’ GRx+

Improve Evaluation of REMS Programs: Study

Yale School of Medicine researchers say there are steps FDA could take to improve the evaluation of elements in Risk Evaluation and Mitigation Strategies (REMS) programs. Writing in JAMA Internal Medicine, the researchers say REMS requirements intended to increase patient and prescriber knowledge of medication safety and risks include medication

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FDA Clarifies Drug Interaction Study Requirements, Labeling Expectations

Rybrevant Faspro OK’d in Aggressive Head and Neck Cancer

Significantly More Unannounced Foreign Inspections

Improve Evaluation of REMS Programs: Study