Industry Briefs

FDA Fast Tracks Alzheimer’s Medication

Alzheon Inc. last month announced that its oral anti-amyloid medication ALZ-801, a prodrug formulation of the compound tramiprosate, was granted fast-track status by the Food and Drug Administration.

Tramiprosate—which was designed to break down amyloid aggregates—failed in a previous clinical trial, but investigators found data to suggest the prodrug version could work in patients with the APOE4 risk gene. Alzheon is initiating a new Phase 3 study of ALZ-801.

FDA Approves Sleep Apnea Implant

The FDA in October approved an implantable neurostimulation device to treat moderate-to-severe central sleep apnea.

Central sleep apnea occurs when the brain fails to send signals to the diaphragm to breathe. The resulting loss of sleep quality can lead to a range of physical and behavioral complications.

The device, called the Remedē System, is an implanted nerve stimulator that sends electrical currents to the phrenic nerve to stimulate the diaphragm and restore normal breathing. The Remedē System, manufactured by Respicardia, is implanted under the skin of the upper chest.

The approval was based on a clinical trial of 141 patients. After six months, more than half of the patients implanted with the Remedē System saw at least a 50 percent reduction in their apnea hypopnea index, which measures the severity and frequency of sleep apnea, compared with only 11 percent of patients in the control group. ■