Welcome Kisunla

We reported previously that the FDA's advisory panel had recommended approval of the monoclonal antibody treatment donanemab.  This followed the successful completion of all three phases of the clinical trial.  This week, the FDA took the advice of the panel and approved donanemab for treatment of some early stage cases of Alzheimer's disease.  Eli Lilly will market donanemab as Kisunla.  

During the clinical trial, test subjects received 700 mg injections of donanemab every 4 weeks for the first 3 doses, and then 1400 mg every 4 weeks (or placebo) for a total of up to 72 weeks.  They demonstrated a statistically significant reduction in clinical decline compared to placebo at Week 76.  At the outset of the study, the study population had a mean age of 73 years, with a range of 59 to 86 years.  Fifty-seven percent of patients were female, 91% were White, 6% were Asian, 4% were Hispanic or Latino, and 2% were Black or African American. 

According to Lilly, “Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%.”

About half of patients (47%) achieved sufficient amyloid-beta clearance to be able to stop treatment after a year, and 69% met that mark by 1.5 years.  Eli Lilly plans to charge about $700 per vial, but I'm not sure how much is in a vial.  Is that one initial dose -- 700 mg?

As a monoclonal antibody for removing amyloid plaques, Kisunla brings the same side effects and risk factors as the other "mabs."  The ones of most concern are some brain swelling and microhemorrhages.  The understanding is that, for most people, the risk is worth the benefit.  These effects are referred to as "amyloid-related imaging abnormalities," or ARIAs.  Treatments must be monitored with periodic brain MRIs.

This is, of course, good news.  Nevertheless, we remember that, when the mabs remove amyloid plaques, they are treating symptoms.  Hopefully we will be seeing treatments that go to the actual core disease itself -- whatever that is.