--- title: 'Regulatory Daily Summary: What Happened on October 19, 2026' headline: FDA approves Roche’s Enspryng for thyroid eye disease description: Viatris added an adult presbyopia use for Ryzumvi. Europe’s drug committee recommended five medicines and reaffirmed one rejection. url: https://thebench.bio/news/regulatory/2026-10-19 topic: regulatory date: '2026-10-19' covers: - '2026-10-19' date_published: '2026-10-19T12:02:04Z' date_modified: '2026-10-19T12:02:04Z' tags: - Regulatory - Industry sources: 4 publisher: TheBench.Bio --- # Regulatory Daily Summary: What Happened on October 19, 2026 **FDA approves Roche’s Enspryng for thyroid eye disease** Viatris added an adult presbyopia use for Ryzumvi. Europe’s drug committee recommended five medicines and reaffirmed one rejection. ## Today in brief The FDA approved Roche’s Enspryng as a self-administered treatment option for thyroid eye disease. [1] Viatris’ Ryzumvi gained FDA approval for adult presbyopia, adding to its existing use for drug-induced pupil dilation. [2] Europe’s CHMP recommended five medicines, while AstraZeneca and Pfizer withdrew applications and the committee upheld its rejection of Omeros’ Yartemlea. [3] ## Europe’s committee recommends five medicines and upholds a rejection The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Kizfizo for specified glioma patients, Yuviwel for children with achondroplasia, Tryngolza for severe hypertriglyceridemia, Rasonque for previously treated metastatic pancreatic cancer, and Eli Lilly’s Foundayo for weight management and type 2 diabetes. [3] The European Commission will make the final decisions on the recommendations. [3] In a 52-week study, children taking Yuviwel grew 1.49 centimeters more per year than children given placebo. [3] A 500-patient Phase 3 study found median overall survival of 12.4 months with Rasonque and 6.7 months with chemotherapy. [3] Phase 3 studies found Tryngolza lowered triglycerides by as much as 72%. Sobi estimates about 700,000 people in Europe’s five largest markets meet the proposed treatment threshold. [3] AstraZeneca withdrew its application to expand Truqap to PTEN-deficient metastatic hormone-sensitive prostate cancer. Pfizer withdrew its application for Ibrance as maintenance treatment in HR-positive, HER2-positive advanced breast cancer. [3] The EMA said independent scan reviews did not clearly confirm the progression-free survival benefit reported by investigators in the Ibrance study. Pfizer plans additional analyses. [3] The CHMP rejected Omeros’ appeal and maintained its negative opinion on Yartemlea, saying the clinical evidence did not reliably establish efficacy. [3] The FDA approved Yartemlea in 2025. [3] ## Viatris adds adult presbyopia to Ryzumvi’s approved uses The FDA approved Viatris’ 0.75% phentolamine eye drops, Ryzumvi, for adults with presbyopia, an age-related loss of near focusing. [2] Ryzumvi was already approved for pharmacologically induced mydriasis, or drug-induced pupil dilation, in adults and children aged 3 and older. [2] In presbyopia studies, 21% of participants had ocular redness and 16% had application-site irritation. [2] Viatris has exclusive US commercialization rights under a worldwide licensing arrangement with Opus Genetics and is seeking a US commercial partner for the new use. [2] ## Also worth knowing - The UK’s Medicines and Healthcare products Regulatory Agency and Northern Ireland’s Department of Health opened an eight-week consultation on October 18 about allowing schools to buy and store spare adrenaline nasal sprays for emergencies. Responses are due by December 14. [4] - The FDA approved Roche’s Enspryng as a self-administered treatment option for thyroid eye disease. [1] ## The day in numbers - **5**: Medicines receiving positive CHMP opinions in October. [3] - **1.49 cm per year**: Additional annual growth reported for children taking Yuviwel versus placebo in a 52-week study. [3] - **12.4 vs. 6.7 months**: Median overall survival with Rasonque and chemotherapy, respectively, in a Phase 3 pancreatic cancer study. [3] ## Also published - [MHRA could allow schools to hold reserves of nasal adrenaline spray](), Pharmaceutical Technology - [Is Participation in MFN Voluntary?](), Pharmaceutical Executive ## Sources 1. [ACT Brief: AI Operating Models, Oncology Evidence Trust, and Thyroid Eye Disease Approval](), Applied Clinical Trials, 2026-10-19 2. [FDA approves Viatris’ Ryzumvi for adult presbyopia](), Pharmaceutical Technology, 2026-10-19 3. [CHMP October decisions: AstraZeneca pulls prostate cancer filing; Orphelia gets a second chance; Ascendis nears EU launch](), European Biotechnology, 2026-10-19 4. [MHRA consults on proposals to allow schools to keep spare adrenaline nasal sprays on site](), MHRA, 2026-10-18 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: