INDIANAPOLS (dpa-AFX) – The US drug manufacturer Lilly (Eli Lilly and) may have to wait even longer for its Alzheimer’s drug with the active ingredient donanemab to be approved in the USA. The responsible US authorities are initially planning a hearing with external consultants, as the pharmaceutical company announced on Friday. The results of an important phase III study with the drug will be discussed. According to the US drug regulator, the FDA is primarily concerned with questions about the safety and effectiveness of the therapy. Lilly shares were moderately weaker in premarket US trading.
The FDA’s decision is a big surprise for Lilly itself, because the authority was actually supposed to decide on approval in a few weeks. The group had expected a message from the drug authority by the end of the first quarter. “We remain convinced of the potential of donanemab,” Anne White, vice president of the group, was quoted in the statement. The company will work with the FDA and respond to all questions. As Lilly further announced, the date for the meeting with the consultants has not yet been set.
The antibody donanemab was tested in patients with early-stage Alzheimer’s disease. The active ingredient targets the protein amyloid in the patient’s brain, which is deposited there in the form of so-called plaques. Side effects such as brain swelling and bleeding occurred in the studies, so regular monitoring is necessary to detect such problems early. Similar side effects were also found in the Alzheimer’s drug from the Japanese manufacturer Eisai and the US partner Biogen, which was approved in July 2023. Biogen shares benefited from the Lilly news and climbed 3.5 percent premarket./tav/stk
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