FDA approval standards based on short-term trials adequately protect long-term antidepressant users

In England, estimated financial costs from adverse childhood experiences were £37.8 billion for mental illness and £22.7 billion for smoking, while in Wales each accounted for £1.8 billion.

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The American College of Obstetricians and Gynecologists noted that more than one in three perimenopausal and postmenopausal women report depressive symptoms

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Satralizumab is a humanized monoclonal antibody designed to bind to soluble and membrane-bound interleukin-6 receptors, inhibiting interleukin-6-mediated inflammatory signaling

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Thyroid eye disease is an inflammatory autoimmune condition affecting an estimated 16 women and 3 men per 100,000 population, commonly occurring in people with hyperthyroidism

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Satralizumab is the first and only at-home subcutaneous treatment cleared by the FDA for adults with thyroid eye disease

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Prior to satralizumab's approval, the FDA approved two intravenous thyroid eye disease treatments targeting the insulin-like growth factor 1 receptor: teprotumumab in 2020 and veligrotug in June 2026

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Satralizumab was initially approved by the FDA in 2020 for neuromyelitis optica spectrum disorder, a rare neuroinflammatory condition

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Satralizumab can be self-administered subcutaneously by a patient or caregiver following initial training from a healthcare provider

552c7ae14Claim

Although satralizumab's SatraGO-1 trial failed to meet its primary efficacy endpoint at week 24, satralizumab received approval based on efficacy results from satralizumab's SatraGO-2

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On October 15, 2026, the U.S. Food and Drug Administration approved satralizumab-mwge (Enspryng), developed by Genentech, for adults with thyroid eye disease

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The FDA approval of satralizumab for thyroid eye disease was based on data from the global phase 3 SatraGO program, which enrolled 258 patients across 19 countries

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In satralizumab's phase 3 SatraGO-2 trial of active thyroid eye disease, 52.9% of satralizumab patients achieved a proptosis response of at least 2 mm reduction (vs. 23.4% placebo) and 60.7% achieved diplopia reduction (vs. 25.8% placebo)

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Roche is studying satralizumab in additional neurologic, autoimmune, and inflammatory conditions that may benefit from interleukin-6 signaling inhibition

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Thyroid eye disease symptoms can include eye swelling, eyelid retraction, a constant stare, proptosis, diplopia, and pain, which can be disfiguring, debilitating, or blinding

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Roche reported that no new safety signals were identified for satralizumab across the phase 3 SatraGO-1 and SatraGO-2 clinical trials

552c7ae14Claim

Satralizumab's phase 3 SatraGO trial program demonstrated consistent efficacy in an overall trial population that included patients with both active and chronic thyroid eye disease

552c7ae14Claim

Genentech's interleukin-6 inhibitor tocilizumab has been studied off-label as a second-line therapy for patients with moderate-to-severe, glucocorticoid-resistant thyroid eye disease

552c7ae14Claim

FDA approval standards based on short-term trials adequately protect long-term antidepressant users

Childhood trauma leads people to develop psychosis

More young people need to get their brain scanned

In England, estimated financial costs from adverse childhood experiences were £37.8 billion for mental illness and £22.7 billion for smoking, while in Wales each accounted for £1.8 billion.

The American College of Obstetricians and Gynecologists noted that more than one in three perimenopausal and postmenopausal women report depressive symptoms

Satralizumab is a humanized monoclonal antibody designed to bind to soluble and membrane-bound interleukin-6 receptors, inhibiting interleukin-6-mediated inflammatory signaling

Thyroid eye disease is an inflammatory autoimmune condition affecting an estimated 16 women and 3 men per 100,000 population, commonly occurring in people with hyperthyroidism

Satralizumab is the first and only at-home subcutaneous treatment cleared by the FDA for adults with thyroid eye disease

Prior to satralizumab's approval, the FDA approved two intravenous thyroid eye disease treatments targeting the insulin-like growth factor 1 receptor: teprotumumab in 2020 and veligrotug in June 2026

Satralizumab was initially approved by the FDA in 2020 for neuromyelitis optica spectrum disorder, a rare neuroinflammatory condition

Satralizumab can be self-administered subcutaneously by a patient or caregiver following initial training from a healthcare provider

Although satralizumab's SatraGO-1 trial failed to meet its primary efficacy endpoint at week 24, satralizumab received approval based on efficacy results from satralizumab's SatraGO-2

On October 15, 2026, the U.S. Food and Drug Administration approved satralizumab-mwge (Enspryng), developed by Genentech, for adults with thyroid eye disease

The FDA approval of satralizumab for thyroid eye disease was based on data from the global phase 3 SatraGO program, which enrolled 258 patients across 19 countries

In satralizumab's phase 3 SatraGO-2 trial of active thyroid eye disease, 52.9% of satralizumab patients achieved a proptosis response of at least 2 mm reduction (vs. 23.4% placebo) and 60.7% achieved diplopia reduction (vs. 25.8% placebo)

Roche is studying satralizumab in additional neurologic, autoimmune, and inflammatory conditions that may benefit from interleukin-6 signaling inhibition

Thyroid eye disease symptoms can include eye swelling, eyelid retraction, a constant stare, proptosis, diplopia, and pain, which can be disfiguring, debilitating, or blinding

Roche reported that no new safety signals were identified for satralizumab across the phase 3 SatraGO-1 and SatraGO-2 clinical trials

Satralizumab's phase 3 SatraGO trial program demonstrated consistent efficacy in an overall trial population that included patients with both active and chronic thyroid eye disease

Genentech's interleukin-6 inhibitor tocilizumab has been studied off-label as a second-line therapy for patients with moderate-to-severe, glucocorticoid-resistant thyroid eye disease

Satralizumab dosing requires three initial loading injections at weeks 0, 2, and 4, followed by maintenance injections every 4 weeks