The approval is based on data from the ongoing Phase IIb/III QUASAR study, which showed that 50% of patients receiving TREMFYA 200 mg and 45% receiving 100 mg achieved clinical remission at week 44 compared to 19% of placebo-treated patients. Additionally, 34% (200 mg) and 35% (100 mg) achieved endoscopic remission in one year.
“There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission,” said Dr. Christopher Gasink, Vice President of Medical Affairs at Johnson & Johnson.
This is the third indication for TREMFYA, which was previously approved for plaque psoriasis and psoriatic arthritis.
Roche’s TECENTRIQ Hybreza Gains Approval as the First Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy
Roche announced that the FDA has approved TECENTRIQ Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous injection in the U.S. This new formulation allows TECENTRIQ to be administered under the skin in about seven minutes, compared to 30-60 minutes for the standard intravenous (IV) infusion. It is approved for all IV indications of TECENTRIQ in adults, including certain lung, liver, skin, and soft tissue cancers.
“By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
The approval is supported by data from the Phase IB/III IMscin001 study, which demonstrated comparable blood levels and consistent safety and efficacy between subcutaneous Tecentriq and the IV formulation. Additionally, the Phase II IMscin002 study showed that 71% of patients preferred TECENTRIQ Hybreza due to shorter clinic time, increased comfort, and reduced emotional distress.
“This approval represents a significant option to improve the patient experience,” said Ann Fish-Steagall, RN, senior VP of Patient Services at the LUNGevity Foundation.
TECENTRIQ Hybreza was first approved in Great Britain in August 2023 and is now available in 50 countries under the name TECENTRIQ SC. Regulatory reviews in other regions are ongoing.
OCREVUS ZUNOVO Receives Approval as the First Twice-a-Year 10-Minute Subcutaneous Injection for Multiple Sclerosis
Roche has announced that OCREVUS ZUNOVO (ocrelizumab & hyaluronidase-ocsq) has been approved by the FDA for treating both relapsing multiple sclerosis and primary progressive multiple sclerosis. This makes OCREVUS ZUNOVO the first and only subcutaneous injection administered by a healthcare professional given just twice a year for both types of multiple sclerosis. This new option aims to provide patients with more flexibility in their treatment plans.
“OCREVUS ZUNOVO gives patients and providers another option for receiving OCREVUS, building on a decade of robust safety and efficacy data,” said Dr. Levi Garraway, Roche’s Chief Medical Officer. “This approval may offer greater flexibility for healthcare providers and people with multiple sclerosis, based on their individual treatment needs.”
Patients can receive OCREVUS ZUNOVO in approximately 10 minutes, with premedications required 30 minutes prior to each dose. Monitoring is required for at least 60 minutes post-injection for the first dose and 15 minutes for subsequent doses.
This FDA approval is based on pivotal data from the Phase III OCARINA II trial, showing no clinically significant difference in OCREVUS levels when administered subcutaneously compared to IV, with consistent safety and efficacy profiles. The study demonstrated a 97% suppression of relapse activity and MRI lesions over 48 weeks. Additionally, over 92% of participants reported satisfaction with the SC administration.
The most common side effects were injection reactions, particularly after the first injection, but all were mild or moderate. Roche continues to lead in multiple sclerosis research, with more than 30 ongoing clinical trials to understand better and improve multiple sclerosis treatment.
Lilly’s EBGLYSS Approved for Moderate-to-Severe Atopic Dermatitis in Adults and Children Aged 12 and Up
Eli Lilly announced that the FDA has approved EBGLYSS (lebrikizumab-lbkz), an IL-13 inhibitor, for treating moderate-to-severe atopic dermatitis in adults and children aged 12 and older weighing at least 88 pounds. EBGLYSS is designed for those whose condition isn’t well-controlled with topical prescription therapies. It targets inflammation throughout the body, which causes symptoms like dry, itchy, and irritated skin.
EBGLYSS is administered as a single monthly injection after an initial dosing phase. The starting dose is 500 mg at weeks 0 and 2, followed by 250 mg every two weeks until week 16. After achieving an adequate clinical response, a maintenance dose of 250 mg is given every four weeks, with or without topical corticosteroids.
“Patients still struggle to control their moderate-to-severe atopic dermatitis with available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives,” said Dr. Jonathan Silverberg, professor of dermatology at George Washington University. “The approval of EBGLYSS is a big win for patients as it offers a new first-line biologic option when topical prescriptions aren’t enough.”
The FDA approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies involving over 1,000 adults and children with moderate-to-severe eczema. After 16 weeks, 38% of participants achieved clear or almost-clear skin (compared to 12% with placebo), with 77% maintaining these results at one year with monthly dosing.
Similarly, itch relief was significant, with 43% of participants feeling relief at 16 weeks, and 85% maintaining that relief for one year. “The approval of EBGLYSS provides hope and promise for the eczema community,” said Kristin Belleson, President and CEO of the National Eczema Association.
The most common side effects of EBGLYSS include eye inflammation, injection site reactions, and shingles. Lilly is committed to working with insurers and providers to ensure patient access through their Lilly Support Services program, offering co-pay assistance for eligible patients.
EBGLYSS has been approved in Europe and Japan, with additional markets expected later this year. Lilly has exclusive development and commercialization rights outside Europe, while Almirall S.A. holds rights in Europe for dermatology indications.
DUPIXENT Granted FDA Approval as the First Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps
Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved DUPIXENT (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 with chronic rhinosinusitis with nasal polyps. This expands on DUPIXENT’s initial approval for adults in 2019, offering a new treatment option for younger patients struggling with uncontrolled symptoms. The approval was fast-tracked under Priority Review, highlighting its potential to improve treatment outcomes.
In discussing the approval, George D. Yancopoulos, M.D., Ph.D., of Regeneron said, “We are pleased to bring the well-established efficacy and safety of DUPIXENT to the many children suffering from chronic rhinosinusitis with nasal polyps, which can make their breathing more laborious and difficult.” Brian Foard, of Sanofi, added, “This latest approval marks the first time a biologic is specifically indicated for adolescents with CRSwNP, offering them an option beyond current standard of care.”
CRSwNP is a chronic condition that causes severe nasal congestion, difficulty breathing, and loss of smell. Traditionally treated with steroids and surgery, many adolescents still experience uncontrolled symptoms. Approximately 9,000 teens in the U.S. live with this condition, making the DUPIXENT approval significant for those seeking better control over their health.
This approval was supported by trials that showed DUPIXENT improved nasal congestion and reduced the need for surgery. The safety profile was consistent with its other uses, making it a viable new option for adolescents struggling with this difficult-to-manage condition.
