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U.S. Regulator Approves Eli Lilly’s Alzheimer’s Drug

The U.S. Food and Drug Administration (FDA) has approved pharmaceutical company Eli Lilly’s (LLY) Alzheimer’s drug called “Donanemab.”

Eli Lilly’s medication for early-stage Alzheimer’s disease is one of only a few treatment options available for the brain disease and is expected to provide the company with blockbuster sales.

The company said it plans to sell Donanemab under the brand name “Kisunla” for adults with early symptoms of Alzheimer’s disease.

There are currently more than 55 million people worldwide living with Alzheimer’s disease, a figure that doubles every 20 years and is forecast to reach 139 million by 2050, according to the group Alzheimer’s Disease International.

The approval of Donanemab has been a long time coming for Eli Lilly. The FDA previously rejected the drug’s approval due to insufficient data.

However, an advisory panel to the FDA recently recommended the treatment for full approval, saying the benefits outweigh the risks in patients.

Donanemab targets toxic plaques in the brain called amyloid that cause Alzheimer’s disease and slows the progression of the disease at the early stages.

The only other treatment for early-stage Alzheimer’s disease currently available is a drug from Biogen (BIIB) called “Leqembi” that was approved last summer.

Eli Lilly’s Kisunla drug is expected to cost $12,500 U.S. for a six-month course and $32,000 U.S. for a 12-month supply.

The approval of the Alzheimer’s treatment comes as Eli Lilly has another blockbuster medication on its hands with its weight loss drug “Zepbound.”

The company has said that it is struggling to keep up with global demand for Zepbound after the weight loss treatment received FDA approval late in 2023.

The stock of Eli Lilly has increased 97% over the past 12 months to trade at $906.71 U.S. per share.