FDA approves a second Alzheimer's drug that can modestly slow disease

The approval of Eli Lilly's Kisunla provides a new option for patients in the early stages of the incurable, memory-destroying ailment.The Associated Press

The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Lilly’s drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling. The new drug's approval was expected after an outside panel of FDA advisors unanimously voted in favor of its benefits at a public meeting last month. That endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels.

More than 6 million Americans have Alzheimer’s. Only those with early or mild disease will be eligible for the new drug, and an even smaller subset are likely to undergo the multi-step process needed to get a prescription. “Certainly getting an infusion once a month is more appealing than getting it every two weeks,” Schindler said.In the company’s study, patients were taken off Kisunla once their brain plaque reached nearly undetectable levels. Almost half of patients reached that point within a year. Discontinuing the drug could reduce the costs and safety risks of long-term use. It's not yet clear how soon patients might need to resume infusions.

Source: Healthcare Press (healthcarepress.net)

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