FDA Approves Roche’s Enspryng for Thyroid Eye Disease

FDA approves Enspryng for thyroid eye disease

The U.S. Food and Drug Administration has approved Roche’s Enspryng, also known as satralizumab, as an at-home subcutaneous treatment for adults with thyroid eye disease, according to Visionmonday.

Roche announced the FDA action for Enspryng in thyroid eye disease, or TED. Visionmonday describes TED as a rare autoimmune disease that can lead to vision-threatening complications if left untreated.

The approval adds an at-home subcutaneous treatment option to the discussion around care for adults with TED. Visionmonday reported that thyroid eye disease affects 155 out of every 100,000 people in the U.S.

Phase 3 findings cited in Roche announcement

According to Visionmonday, the FDA decision was based on phase 3 studies. Roche said the studies demonstrated a significant reduction in eye bulging and improvement in diplopia, along with a favorable safety profile.

For pharmaceutical and biotech sales professionals, the FDA action centers on the approved use of Enspryng for adult thyroid eye disease and its at-home subcutaneous administration. The clinical points cited in Roche’s announcement include eye bulging, diplopia and safety findings from phase 3 studies.

Visionmonday’s report identifies the FDA approval, adult TED population and at-home subcutaneous treatment format as the principal elements of Roche’s announcement. Roche characterized the phase 3 results as showing significant reduction in eye bulging, improvement in diplopia and a favorable safety profile.

Key details from the report

• Roche’s Enspryng received FDA approval for adults with thyroid eye disease.
• Visionmonday reported that the treatment is administered subcutaneously at home.
• Roche cited phase 3 studies in its announcement.
• Roche said the studies showed a significant reduction in eye bulging and improvement in diplopia.
• Roche also cited a favorable safety profile.