Health · Pharma & Biotech · 5 hrs ago
US approves Roche's Enspryng for thyroid eye disease
The US FDA approved Roche's Enspryng for adults with thyroid eye disease on Thursday.
The condition is a rare autoimmune disease in which tissue behind the eyes becomes inflamed and can push the eyes forward.
Enspryng is the first treatment for the disease that patients can inject under the skin at home.
The approval was based on two Phase III studies with 258 participants from 19 countries.
In one study, 53% of patients given Enspryng had at least a 2-millimetre reduction in eye protrusion, compared with 23% given a placebo.
The results showed a greater reduction in eye protrusion with Enspryng in that study.
The treatment is now approved in the US for adults with the condition.
Roche has received US approval for Enspryng to treat adults with thyroid eye disease.
The drug is the first at-home treatment for the condition that patients can inject under the skin themselves.
Approval was based on two Phase III studies involving 258 participants in 19 countries.
In the SatraGo-2 study, 53% of patients receiving Enspryng had at least a 2-millimeter reduction in eye protrusion, compared with 23% receiving placebo.
- Who
- Roche and adults with thyroid eye disease.
- What
- The US approved Enspryng, also known as satralizumab, to treat the condition.
- When
- The approval was announced in October 2026. The articles differ on whether Roche announced it on Thursday or Friday.
- Where
- The United States.
- Why
- To provide a treatment for thyroid eye disease, an autoimmune condition that can cause inflammation behind the eyes and eye protrusion.
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- Drug
- Enspryng (satralizumab)
- Studies
- SatraGo-1 and SatraGo-2; 258 participants across 19 countries
- SatraGo-2 result
- 53% with Enspryng had at least a 2-millimeter reduction in eye protrusion, versus 23% with placebo
- Other approval
- Enspryng has been approved in around 90 countries since 2020 for another autoimmune disease