(Reuters) – Eli Lilly has requested Europe’s medicines regulator to re-examine its opinion on the company’s Alzheimer’s drug, the agency said on Friday. Last month, the regulator had rejected the drug, Kisunla, saying that the treatment’s ability to slow cognitive decline was not large enough to outweigh the risk of serious brain swelling in patients. […]
Health
Lilly requests EMA to re-examine Alzheimer’s drug recommendation
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(Reuters) – Eli Lilly has requested Europe’s medicines regulator to re-examine its opinion on the company’s Alzheimer’s drug, the agency said on Friday.
Last month, the regulator had rejected the drug, Kisunla, saying that the treatment’s ability to slow cognitive decline was not large enough to outweigh the risk of serious brain swelling in patients.
Lilly had said at the time that it planned to seek a re-examination from the regulator.
Upon receiving the grounds of the request, the agency said it will reconsider its opinion and issue a final recommendation for the drug.
Lilly’s drug is already approved in the United States.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Saumyadeb Chakrabarty)