The European Medicines Agency (EMA) has granted limited approval to Eli Lilly’s (LLY) new Alzheimer’s drug Kisunla, reversing an earlier decision to reject the drug over concerns of brain swelling and bleeding in patients.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
The treatment for early-onset Alzheimer’s, which is administered via a monthly infusion, has already been approved in the U.S., United Kingdom (U.K.), Japan and China. In March, the European Medicines Agency human medicines committee rejected the drug, saying there was a risk of “potentially fatal events” due to brain injuries and bleeding.
But now, after re-examining the drug at the request of Eli Lilly, the medicines committee has recommended granting Kisunla marketing authorization for a limited number of patients who do not have a copy, or only have one copy, of the ApoE4 gene that puts them at a greater risk of Alzheimer’s disease.
Controlled Access
The EMA said the treatment should be administered as part of a controlled access program and under the supervision of physicians trained in managing potentially dangerous symptoms. It also mandated measures aimed at mitigating risks, including more stringent rules for stopping treatment, and said that patients administered Kisunla must start with a low dose.
“This positive opinion marks a significant milestone in our efforts to bring (Kisunla) to eligible patients across Europe,” said Patrik Jonsson, President of Eli Lilly International, in a written statement. “(Kisunla) has the potential to make a meaningful difference for people living with early symptomatic Alzheimer’s disease.”
Is LLY Stock a Buy?
The stock of Eli Lilly has a consensus Strong Buy rating among 19 Wall Street analysts. That rating is based on 16 Buy, two Hold, and one Sell recommendations issued in the last 12 months. The average LLY price target of $1,006.80 implies 26.02% upside from current levels.
