The US Food and Drug Administration (FDA) has granted Roche a label expansion for its ophthalmology therapy, Enspryng (satralizumab), in thyroid eye disease (TED), with the benefit of an at-home administration.
This means that the interleukin 6 (IL-6) inhibitor is now greenlit for use in adults with TED – a condition where the body’s own cells attack the muscles, tear glands and connective tissues behind the eyes. Following its label expansion, healthcare providers can now prescribe Enspryng to either be self- or caregiver-administered once every four weeks during the maintenance phase of treatment.
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Currently, researchers estimate that TED, which is otherwise known as Graves’ ophthalmopathy, impacts around 155 to 250 people per 100,000 globally.
The FDA gave Enspryng the TED green light based on the totality of data from the drug’s Phase III SatraGO programme (NCT05987423; NCT06106828). While the drug did not meet its pre-specified primary endpoints in SatraGO-1, patients with both active and chronic TED experienced significant improvements in both double vision and the degree to which their eyeballs bulge.
Analysts question commercial impact of Enspryng’s TED market debut
Enspryng’s newfound approval expands the drug’s role from its original US approval in neuromyelitis optica spectrum disorder (NMOSD), which came back in 2020. It also makes it the first drug to get the FDA’s blessing as a subcutaneous treatment option in TED, as marketed options , Amgen’s Tepezza (teprotumumab-trbw) and Viridian Therapeutics’ recently greenlit therapy, Lumvoa (veligrotug-vvze), are intravenously administered.
However, William Blair analysts note that, despite Enspryng’s place as a first-in-class, subcutaneous addition to the TED treatment paradigm, they do not view the drug as a “major competitive threat” to the anti-IGF-1R class – including drugs like Tepezza and Lumvoa.
“We have seen limited excitement for the anti-IL-6 mechanism among doctors. The anti-IGF-1R class is still seen as the gold standard for treating TED, and the data from the SatraGO studies simply does not look particularly competitive,” they added.
Though the analysts point to the importance of subcutaneous options in expanding the TED market, they do not believe that the current data will allow the IL-6 drug class to “supplant anti-IGF-1R therapies as the standard of care for a majority of patients”.
There are currently several drugs in mid-to-late-stage development for TED, including Novartis-owned Tourmaline Bio’s rival anti-IL-6 therapy, pacibekitug, as well as Sling Therapeutics’ dual ATP-competitive kinase inhibitor pill, linsitinib.
Currently, analysts at GlobalData, the parent company of Pharmaceutical Technology, estimate that Enspryng will generate $825m in sales in 2032.
