European Regulators Back New Alzheimer's and HIV Prevention Treatments

Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for several groundbreaking treatments, including Eli Lilly's Alzheimer's drug Kisunla and Gilead Sciences' long-acting HIV prevention injection Yeytuo. These positive opinions mark significant advancements in addressing two major global health concerns.

Kisunla Receives Conditional Approval for Early Alzheimer's

Four months after an initial rejection, the CHMP has endorsed Eli Lilly's Alzheimer's treatment Kisunla, albeit with restrictions. The positive opinion covers the drug's use in patients with early Alzheimer's symptoms who have one or no copies of the apolipoprotein E ε4 (ApoE4) gene. This limitation mirrors the one applied to Eisai and Biogen's Leqembi, which received marketing authorization in Europe three months ago.

The restriction addresses concerns over amyloid-related imaging abnormalities (ARIA), a primary side effect of current Alzheimer's treatments. Patients carrying two copies of the ApoE4 gene are more susceptible to ARIA and are not recommended for Kisunla treatment.

Lilly's path to approval in Europe echoes its experience with U.S. regulators. The company secured FDA approval for Kisunla in July 2024, followed by a recent endorsement of a new dosing regimen. This updated protocol, featuring a more gradual titration, significantly reduces the rate of ARIA-related brain swelling and is included in the CHMP's recommendation.

Gilead's Yeytuo: A Breakthrough in HIV Prevention

The CHMP has also given a positive opinion on Gilead Sciences' HIV pre-exposure prophylaxis (PrEP) treatment, Yeytuo (lenacapavir). This twice-yearly subcutaneous injection represents a major advancement in HIV prevention efforts.

Yeytuo's recommendation applies to both adults and adolescents and was granted under an accelerated pathway due to its potential public health impact. The treatment was evaluated under the EU-Medicines for all program, which included participation from the World Health Organization and regulators from several African and Asian nations.

Dr. Dietmar Berger, Gilead's chief medical officer, emphasized the potential of lenacapavir for PrEP to become a critical tool in public health, expanding prevention options for those facing the highest barriers to care.

Additional CHMP Endorsements

The CHMP has also recommended several other treatments for various conditions:

• Zurzuvae for postpartum depression, developed by Sage Therapeutics and recently acquired by Supernus Pharmaceuticals
• IntraBio's Aqneursa for Niemann-Pick disease type C
• KalVista Pharmaceuticals' Ekterly, the first oral treatment for hereditary angioedema recommended in Europe
• Ono Pharmaceuticals' Romvimza for tenosynovial giant cell tumor
• Ionis Pharmaceuticals' Tryngolza for familial chylomicronemia syndrome
• Servier's Voranigo for low-grade astrocytoma or oligodendroglioma

These recommendations reflect ongoing advancements in treating rare diseases and expanding treatment options for patients across various therapeutic areas.