The global pharmaceutical landscape is witnessing significant shifts driven by health regulators in the U.S. (FDA), Europe (EMA), and China (NMPA). Here are the highlights:
Hurdles in the European market
-
Rett Syndrome: Acadia Pharmaceuticals reported a negative trend vote from the EMA’s CHMP regarding trofinetide. Despite being the first approved treatment for this neurodevelopmental disorder in the U.S., Canada, and Israel, it faces a likely rejection in the EU. Acadia plans to request a re-examination.
Major approvals in China and Japan
-
Respiratory conditions: * GSK secured two wins in China: Nucala became the first monthly biologic for COPD, and Trelegy was approved for adult asthma.
-
In Japan, GSK’s Exdensur was endorsed as the first ultra-long-acting biologic for severe asthma and chronic rhinosinusitis with nasal polyps.
-
-
Gastric Cancer: The AstraZeneca and Daiichi Sankyo alliance earned a sixth nod for their blockbuster Enhertu in China, now approved as a second-line treatment for HER2-positive metastatic gastric cancer.
U.S. FDA updates
-
Alzheimer’s Disease: The FDA accepted a priority review for an autoinjector version of Leqembi (Biogen & Eisai). If approved by May 2024, it would be the first anti-amyloid treatment available for at-home initiation and maintenance.
-
Weight loss drug labels: The FDA requested Novo Nordisk and Eli Lilly to remove suicidal ideation warnings from labels for Wegovy, Zepbound, and Saxenda, citing data that show no increased risk.
-
Contraceptive updates: Organon’s Nexplanon implant received approval for extended use, increasing its duration from three years to five years.
Source: https://www.fiercepharma.com/pharma/fierce-pharma-regulatory-tracker-2026