United States – Federal regulators paused in coming to a decision as regards whether to approve the Eli Lilly drug for Alzheimer’s by making a highly unusual move of asking outside advisers to appraise the treatment.
FDA’s Unusual Move
Lilly figured that the FDA would have already made a final decision on Donanemab’s approval by the end of that month. However, the drug producer noted Friday that the FDA wanted more data concerning the safety and efficacy of the drug, as reported by the Associated Press.
The date of the advisory committee meeting is not yet scheduled.
FDA frequently orders reviewing committees to analyze drugs, which represent the only existing class of treatment. Donanemab, if this drug will be approved, would follow like Eisai’s Leqembi which was granted a year ago and Biogen’s Aduhelm.
Ann White, Foot Executive Vice President of Lilly said that Lilly still stays committed to donanemab and will cooperate with the FDA in this.
The agency seeks to learn how a pivotal trial conducted by Lilly can tell more about the drug.
Donanemab’s Promising Trial Results
The 18-month phase III study showed that patients given Donanemab showed a decline of about 22% slower in terms of their memory and cognitive function compared with those who received an infusion of a placebo. It was about four to seven months long.
A study showed that when patients’ low-levels-of-plaque brains were taken off the drug, their performance improved significantly. The greatest number of patients came about within a year.
Donanemab has the credential of becoming the second FDA-approved drug to slow the disease progression. The other is Leqembi.
Earlier this year, Biogen decided to discontinue the sales of Aduhelm.
Serious Side Effects and Monitoring
The sickness and the drug cure Leqembi and Lilly’s treatment are both mild or at the very beginning stages in the disease that is deadly. The IV infusion would attack the etiological factor of the deadly Alzheimers, the formation of amyloid plaque.
As with Lembect, Donanamabe also has these serious side effects, including brain swelling and bleeding. There is the possibility for those drugs to cause undesirable effects like increased cholesterol levels and blood sugar levels, which require monitoring, as reported by the Associated Press.
According to the trial, about a quarter of all recipients displayed symptoms of swelling, while around 20% had small bleeding across the brain.