The U.S. Food and Drug Administration (FDA) has given the green light to Leqembi, marking the first Alzheimer's drug to receive full approval from U.S. authorities in the last twenty years. The drug's active ingredient, lecanemab, is exclusively produced at Biogen's new factory located in north-west Switzerland.
Luterbach, a town in the canton of Solothurn, is not typically a hotspot for the biopharmaceutical industry. However, it has gained global significance as the FDA approved Leqembi, the first drug for the neurodegenerative disease to receive full approval by U.S. authorities in two decades. While not a cure, the drug has demonstrated its ability to slow cognitive decline in patients in the early stages of the disease. Clinical trial data suggested that this could slow decline by approximately 27% over an 18-month period.
The FDA indicated in its approval that the Leqembi approval is widely considered a milestone as it's the only approved therapy that addresses the "underlying disease process" rather than merely the symptoms of the brain disorder. Luterbach, home to just over 3,600 people, houses the only global production site of the active ingredient in Leqembi, developed by the Japanese company Eisai and sold in partnership with U.S. biotech firm Biogen.
The Luterbach factory, which began operations in 2021, is responsible for four stages of the production process. This includes the cultivation of mammalian cells at a quantity large enough to manufacture the product, a fed-batch process, a series of purification steps, and the formulation stage. The factory is expected to triple Biogen’s biologics production, which currently includes several products for neurological diseases such as multiple sclerosis.
Biogen's ties to Switzerland date back to its founding in Geneva in 1978. The company moved its headquarters to Cambridge, Massachusetts in 1982 but established its international headquarters in Baar, in canton Zug, where it employs around 400 people.
Whether Swissmedic, which received an application for approval in May, will also approve Leqembi and its price are still to be seen. A decision by Swissmedic is expected in autumn 2024.
Luterbach, a town in the canton of Solothurn, is not typically a hotspot for the biopharmaceutical industry. However, it has gained global significance as the FDA approved Leqembi, the first drug for the neurodegenerative disease to receive full approval by U.S. authorities in two decades. While not a cure, the drug has demonstrated its ability to slow cognitive decline in patients in the early stages of the disease. Clinical trial data suggested that this could slow decline by approximately 27% over an 18-month period.
The FDA indicated in its approval that the Leqembi approval is widely considered a milestone as it's the only approved therapy that addresses the "underlying disease process" rather than merely the symptoms of the brain disorder. Luterbach, home to just over 3,600 people, houses the only global production site of the active ingredient in Leqembi, developed by the Japanese company Eisai and sold in partnership with U.S. biotech firm Biogen.
The Luterbach factory, which began operations in 2021, is responsible for four stages of the production process. This includes the cultivation of mammalian cells at a quantity large enough to manufacture the product, a fed-batch process, a series of purification steps, and the formulation stage. The factory is expected to triple Biogen’s biologics production, which currently includes several products for neurological diseases such as multiple sclerosis.
Biogen's ties to Switzerland date back to its founding in Geneva in 1978. The company moved its headquarters to Cambridge, Massachusetts in 1982 but established its international headquarters in Baar, in canton Zug, where it employs around 400 people.
Whether Swissmedic, which received an application for approval in May, will also approve Leqembi and its price are still to be seen. A decision by Swissmedic is expected in autumn 2024.