The US Food and Drug Administration (FDA) has approved three medicines in the space of a week, each for a specific group of adult patients: an at-home injection for thyroid eye disease, a once-monthly injection for schizophrenia and a new antiviral tablet for herpes lesions that no longer respond to standard treatment.
Roche announced on October 16, 2026 that the FDA approved Enspryng (satralizumab) "for the treatment of adults with thyroid eye disease (TED)", an autoimmune condition that can push the eyes forward and cause double vision. Patients or caregivers can inject it under the skin at home after training from a healthcare provider, every four weeks during the maintenance phase. Roche says it is the only treatment for the disease that patients can inject under the skin at home. Enspryng was first approved in 2020 for neuromyelitis optica spectrum disorder.
The approval rests on two Phase III trials with 258 patients in 19 countries. In SatraGO-2, 52.9% of patients with active disease had a reduction in eye bulging, compared with 23.4% on placebo, while the SatraGO-1 trial did not meet its main goal at week 24. Roche said no new safety signals were identified.
Teva announced on October 9 the approval of Weltruza (olanzapine) for extended-release injectable suspension, given once a month under the skin for the treatment of schizophrenia in adults. It is based on the Phase 3 SOLARIS trial in adults aged 18 to 64, and comes in three strengths, 318 mg, 425 mg and 531 mg, matching daily oral olanzapine doses of 10 mg, 15 mg and 20 mg. Teva says it needs no loading doses, no added tablets and no monitoring after each injection. Like other medicines of its class, it carries a boxed warning of increased risk of death in older adults with dementia-related psychosis, a use for which it is not approved. Teva expects it to reach US patients in the coming weeks.
Asahi Kasei Therapeutics announced on October 9 the approval of Hovilpri (pritelivir) 100 mg tablets for immunocompromised adults with mucocutaneous lesions caused by herpes simplex virus that are refractory, with or without documented resistance, to acyclovir, valacyclovir or famciclovir. In the PRIOH-1 trial of 101 patients, 63% of those on Hovilpri had complete lesion healing by day 28, compared with 34% on the doctor's choice of treatment. Roche plans to make it available in the United States by the end of 2026.
