The Biogen-developed treatment, called lecanemab, appears to have a more clear-cut effect on slowing the disease than the company’s previous Alzheimer’s drug, Aduhelm.
The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.
The FDA has given the green light to the first major new classes of antidepressant therapies in decades, opening up new avenues for therapeutic development.
At $2 million for a single dose, Novartis’s Zolgensma is the most expensive medicine to date, but still less expensive over a lifetime than another approved drug for the rare genetic disease.
Clinicians and researchers teamed up to investigate how inappropriate proinflammatory mechanisms contribute to the pathogenesis of drug-refractory epilepsy.