A stark transatlantic regulatory divide isolates patients in one hemisphere from life-changing orphan therapies.
The growing regulatory and philosophical division between the FDA and the EMA over historical data validity and trial endpoints splits the market, stranding patients with rare diseases without approved treatments in one region.
The same conclusion keeps arriving from across the workspace's research — 1 topics independently instantiate this theme. Filter the evidence by where it came from:
European approvals based on a landmark neuroinflammation trial have not been matched in the U.S., stalling patient access to the first disease-progression multiple sclerosis therapy.
European regulators rejected a rare and life-saving transplant drug on clinical data that was deemed fully sufficient to secure an active commercial approval from the FDA.
The EMA's rejection of Omeros's rare transplant therapy creates a severe geographic divide, keeping European patients from accessing a drug already approved in the United States.