“A safe and effective treatment”

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INNOVATION

The US FDA approves the Alzheimer’s drug Leqembi.Archive image.

The American pharmaceutical authority FDA has approved a new Alzheimer’s drug, writes CNBC.

Lecanemab, which is marketed under the brand name Leqembi, has been developed by the American pharmaceutical company Biogen and Japan’s Eisai and is based on a discovery by the Swedish pharmaceutical company Bioarctic.

Leqembi received so-called accelerated approval by the FDA earlier this year for patients with mild or early Alzheimer’s.The FDA has now reviewed more extensive studies before the drug received full approval.

“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” said Teresa Buracchio of the FDA in a statement.

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With the FDA’s approval, it means that costs for the treatment are covered within the Medicare health care program, AP writes.

Medicare has blocked Leqembi and a similar drug, Aduhelm, pending full FDA approval.

Swedish Bioarctic holds a royalty on the global sale of lecanemab.

FACTS

Based on Swedish discovery

Lecanemab is an antibody directed against a variant of a protein called beta-amyloid.Accumulations of beta-amyloid in the brain are believed by many researchers to be what causes Alzheimer’s disease.

In the past, several other antibodies directed against beta-amyloid have failed to slow the progression of the disease.Lecanemab works by targeting a special variant of the protein, so-called protofibrils, which researchers behind the drug believe are particularly harmful.

The drug is based on a discovery by Swedish researcher Lars Lannfeldt, professor at Uppsala University.His research group identified a change in the genetic mass of a northern Swedish family that was severely affected by Alzheimer’s disease.

The drug, which is not yet approved in Sweden, has been developed, among other things, by the Swedish company Bioarctic, which Lars Lannfeldt co-founded.

Sources: Uppsala University and Bioarctic