Leqembi and Kisunla

Certain Alzheimer’s drugs, Leqembi and Kisunla, increase a patient’s risk for swelling and brain bleeds, but only when the patient has one of certain impacted genetic profiles. These drugs have been approved by the FDA after clinical trials. Recently, a New York Times investigation found that in clinical studies with 2000 volunteers, Eisei, the manufacturer of Leqembi had tested to determine their genetic profiles, but didn’t notify the ones with high risk for brain bleeds and swelling. This means that these patients did not give informed consent for the clinical study. If you suffered brain bleeds or swelling in the course of a clinical trial for Leqembi or Kisunla, anti-amyloid monoclonal antibody drugs, you may be able to recover compensation. You should contact the seasoned Chicago-based product liability attorneys of Moll Law Group about your legal options. Billions have been recovered in cases with which we’ve been involved. 

Leqembi and Kisunla are IV infusions that attack a protein, amyloid, that is involved in Alzheimer’s; amyloid gets concentrated in plaques of the brains of Alzheimer’s patients. Each drug carries safety risks, but both are considered able to slow down dementia. Leqembi is an infusion that is administered every two weeks, while Kisunla is a monthly infusion. Patients can stop dosing with the latter drug once the proteins are removed, but the same is not true for the former. These drugs represent only incremental steps toward effective Alzheimer’s treatments. 

When the drug manufacturers ran Phase 3 trials for Leqembi and Kisunla, participants were given genetic tests to determine whether they carried the ApoE4 gene—when people carry two copies of the ApoE4 gene, one from both mother and father (ApoE4 homozygotes), they have a notably higher risk of brain swelling and bleeding in the course of taking these drugs.

Around 1 out of 6 volunteer participants carried two copies of the gene, but neither manufacturer disclosed the risk to the participants, and their genetic status was only revealed at the end of the study, after taking the risky drugs. This may have undermined informed consent, though some argue that the link between ApoE4 homozygotes and brain bleeds or swelling weren’t as clear as they are now at earlier points in time.

Ultimately, three doses of Leqembi led to a volunteer dying. An autopsy revealed that the cause of death with was partly the result of side effects from Leqembi. Another patient died as well. Over 100 other volunteers suffered from brain bleeds and swelling, too. Dozens suffered severe abnormalities in connection with Kisunla.

While there are potential good effects involved in Leqembi and Kisunla, some doctors don’t prescribe it, and they haven’t been cleared in every country because it’s believed that the help these drugs provide may be minor. It’s terrifying then, to realize that multiple people may have suffered serious injuries because they weren’t given adequate information for a drug with modest benefits and a mixed response from the medical communities worldwide.

The form signed by volunteers let them know they’d be tested for a genetic profile that meant they had a higher chance of bleeding abnormalities including brain swelling and cerebral microhemorrhages. However, the form also indicated these were “for research purposes” and wouldn’t be shared with the participant, insurance companies, employers, family members or treating physicians. The trial included 957 people with one copy of the risky gene and 274 with two copies.

An important principle of clinical studies is that patients are given enough information about increased risks involved in the medication is being tested that they can give informed consent to participate. A patient can’t provide informed consent in situations where certain important information about the risks is withheld from them. However, these cases may be complex, since the volunteers in both trials were asked to sign consent forms that noted that some people with specific genetic profiles would face higher brain injury risks and would be tested, but they wouldn’t be told about the results of testing. 

If you were injured or a loved one died due to Leqembi or Kisunla, call the seasoned Chicago-based product liability attorneys of Moll Law Group to talk about your legal options. Please complete our online form or call us at 312.462.1700 for a free consultation. We represent clients around the country.