In Reversal, European Regulators Back Lilly's Alzheimer's Drug Kisunla

Eli Lilly's Alzheimer's drug Kisunla (donanemab) has received a positive opinion from a key European Medicines Agency (EMA) committee, marking a significant turnaround in the drug's path to European market entry. This development puts Kisunla one step closer to joining the arsenal of treatments available for Alzheimer's patients in Europe.

EMA Committee Changes Stance on Kisunla

The EMA's Committee for Medicinal Products for Human Use (CHMP) has reversed its earlier negative recommendation, now supporting the authorization of Kisunla for early symptomatic Alzheimer's disease in certain adults. This decision comes after Lilly appealed the committee's initial rejection in March, which had cited safety concerns related to amyloid-related imaging abnormalities (ARIA).

The new positive opinion recommends Kisunla for patients with one or no copies of the APOE4 gene, which is believed to increase the risk of ARIA. This targeted approach reflects a careful balance between the drug's potential benefits and its known safety risks.

Safety Concerns and Clinical Data

Kisunla, like other drugs in its class, has been associated with ARIA, which can cause brain swelling and small-scale bleeding. Clinical trials revealed that nearly 37% of participants receiving Kisunla experienced these effects, compared to just under 15% in the placebo group.

Despite these concerns, the CHMP's reversal suggests that the potential benefits of Kisunla in slowing the progression of Alzheimer's disease outweigh the risks for certain patient populations. This decision aligns with recent regulatory trends, as evidenced by the EMA's approval of Eisai's similar Alzheimer's drug, Leqembi, following an appeal.

Global Regulatory Landscape and Market Potential

Kisunla has already secured marketing approvals in Japan, China, the United Kingdom, and the United States. The positive opinion from the CHMP paves the way for potential authorization by the European Commission, which has the final say on approval for the European market.

With an estimated 7 million people living with Alzheimer's in Europe—a number expected to nearly double by 2050—the potential market for Kisunla is substantial. Analysts predict peak annual sales could reach into the billions, underscoring the drug's significance for both patients and Eli Lilly's growth strategy.

Patrik Jonsson, president of Lilly International, called the CHMP's new opinion "a significant milestone" in the company's efforts to bring Kisunla to eligible patients in Europe. As the aging population increases, the demand for effective Alzheimer's treatments is likely to grow, highlighting the importance of continued research and development in this field.