Evicenter
P&T meetings

SKY-0515

Huntington's disease

Last updated
211 sources

Product information and disease descriptionProduct descriptionProduct information

Contraindications/Warnings/Precautions/Adverse effects

3 evidence topics · 3 sources

Warnings and precautions
FDA-approved prescribing information, contraindications, boxed warnings, and REMS

Not applicable.

Most common adverse events observed in clinical studies

“In SKY-0515-001 Part Cii and its Extension, the most common related treatment-emergent adverse events in HD participants (reported by two or more participants) were headache, diarrhea, and nausea, with the majority of events mild or moderate in severity.” (opens the source at this quote in a new tab)

Peripheral neuropathy monitoring

“There have been no TEAEs suggestive of peripheral neuropathy in participants with HD during the 9 months treatment period.” (opens the source at this quote in a new tab)

Class context: prior splice modulator branaplam

“Previously, another splice modulator called branaplam, developed by Novartis, had significant side effects in people with HD causing the trial to halt early” (opens the source at this quote in a new tab)