Alzheimer research

 

Female chemist looking into microscope. isabel Höjman/TT  

Alzheimer research 

Unanimous FDA panel gives green light: “Robust results” 

 

The six advisors in the FDA's expert panel are unanimous and recommend that Bioarctic's Alzheimer's drug lecanemab should receive full approval in the United States, writes Reuters.  

 

The study shows "clear clinical benefit" and the results are "robust", says Robert Alexander, chairman of the advisory committee. 

 

- I consider the benefit relative to the risk to be beneficial, acceptable and in line with this type of treatment, says panel member Tanya Simuni, professor of neurology.  

 

The American pharmaceutical authority FDA gives its final announcement by July 6 at the latest. The authority rarely goes against its expert panel. 

 

Archive image. AP  

 

FDA panel gives thumbs up to Bioarctic's lecanemab  

 

Bioarctic's drug lecanemab is showing clinical benefit against Alzheimer's, the US Food and Drug Administration's FDA advisory committee announced late Friday evening, according to Reuters. 

 

The panel unanimously agreed that the Swedish company's study 301 (Clarity AD) confirms the benefits of treatment against the disease in an early stage.  

 

The announcement paves the way for the FDA to give full approval in the US by July 6 at the latest, as the pharmaceutical authority very rarely goes against its expert panel.  

 

Under the brand name Leqembi, the drug received a so-called accelerated conditional approval by the FDA in January on the American market.  

 

Bioarctic's share rose nearly 6 percent to a new record level ahead of the announcement. The American partner company Biogen was suspended before the announcement.