Un medicament pentru o boală rară, suspendat în Marea Britanie | Autoritățile spun că studiul care i-a susținut aprobarea nu mai este de încredere

The UK Medicines Authority has suspended the use of Tavneos for new patients due to unreliable clinical trial data. The decision affects the treatment of rare autoimmune diseases. Patients currently on the medication can continue for up to six months while alternatives are considered. Amgen disputes the ruling, arguing that sufficient evidence supports the drug's efficacy and safety. Similar actions have been taken in the EU and the US, where the FDA has also proposed withdrawal due to safety concerns. The case highlights the importance of reliable data in drug approval processes.