The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

You are here: Home / Archives for Approvals

FDA approves TZIELD™ (teplizumab-mzwv) to delay the onset of Stage 3 type 1 diabetes

by

On November 17, 2022, the US Food and Drug Administration (FDA) approved TZIELD™ (teplizumab-mzwv) to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. The approval was based in part on a clinical trial in Stage 2 T1D patients in which TZIELD delayed the median onset of Stage 3 T1D by 25 months, or approximately 2 years, compared to placebo.

Teplizumab is a humanized, anti-CD3e IgG1k antibody originally developed at Tolerance Therapeutics, Inc. and the University of California. The antibody Fc region was mutated (L234A; L235A) to reduce effector functions. Teplizumab binds CD3 expressed on mature T cells and may induce expansion and/or regulatory function in T cell subsets. In 2005, teplizumab was licensed to MacroGenics. In 2018, Provention Bio acquired all rights to teplizumab and subsequently continued its development for the prevention and treatment on T1D. The FDA granted teplizumab Orphan Drug designation for the treatment of recent-onset T1D. Teplizumab was also granted FDA’s Breakthrough Therapy designation for the prevention or delay of clinical T1D in at-risk individuals and EMA’s PRIority MEdicines (PRIME) designation for the same indication. As of October 2022, Provention Bio and Sanofi had entered into a co-promotion agreement for teplizumab.

Provention Bio is currently evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D in the global PROTECT (PROvention T1D trial Evaluating C-peptide with Teplizumab) Phase 3 study (NCT03875729). This randomized, double-blind, placebo-controlled, multicenter trial will enroll 300 patients with recent onset T1D who will be randomized 2:1 to either two 12-day cycles of teplizumab (IV) or placebo. The primary efficacy endpoint is C-peptide change. Secondary endpoints include insulin use, HbA1c, hypoglycemic episodes, and safety. The company expects top line data from PROTECT Phase 3 study in 2H 2023.

Interested in more information about approved antibody therapeutics? Explore our searchable table of antibody therapeutic products for details.

 

European Commission approves Beyfortus® (nirsevimab) for the prevention of RSV disease

by

The European Commission (EC) has approved AstraZeneca and Sanofi’s Beyfortus® (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. Nirsevimab is human IgG1ҡ antibody targeting RSV. The Fc domain was engineered using AstraZeneca’s proprietary YTE half-life extension technology. Developed by AstraZeneca and Sanofi, nirsevimab is designed to offer newborns and infants direct protection against RSV and help prevent RSV-related lower respiratory tract infections.

Nirsevimab received regulatory designations to facilitate development, including a Promising Innovative Medicine designation from the UK Medicines and Healthcare Products Regulatory Agency; Breakthrough Therapy designation from China’s NMPA; Breakthrough Therapy designation from FDA; and PRIME designation from EMA. In addition, it was named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by Japan’s Agency for Medical Research and Development. The approval by the EC was based on results of the Phase 3 MELODY (NCT03979313), Phase 2/3 MEDLEY (NCT03959488), and Phase 2b (NCT02878330) clinical trials.

The Phase 2b trial is a randomized, placebo-controlled trial designed to measure the efficacy of nirsevimab in preventing medically attended RSV-related lower respiratory tract infections through 150 days post-dose. The study was conducted on healthy preterm infants (29–35 weeks’ gestation) who were randomized (2:1) to receive a single intramuscular injection of nirsevimab (50 mg) or placebo. The primary endpoint of the study was met, with a reduction of the incidence of medically attended RSV-related lower respiratory tract infections by 70.1% (95% CI: 52.3, 81.2) compared to placebo.

MELODY is a randomized, placebo-controlled Phase 3 trial evaluating the safety and efficacy of nirsevimab for the prevention of medically attended lower respiratory tract infections in healthy late preterm and term infants (i.e., born at 35 weeks’ gestation or later). Participants (n=1490) up to 1 y of age were randomized (2:1) to receive a single intramuscular injection of nirsevimab (50 mg if <5 kg or 100 mg if >5 kg body weight) or placebo. The primary endpoint of this study was met, with a reduction in the incidence of medically attended lower respiratory tract infections caused by RSV of 74.5% (95% CI 49.6, 87.1; P<0.001) compared to placebo.

The randomized, double-blind, palivizumab-controlled Phase 2/3 MEDLEY study evaluated the safety and pharmacokinetics of nirsevimab compared to palivizumab in preterm infants and infants with congenital heart disease and/or chronic lung disease of prematurity eligible to receive palivizumab entering their first RSV season. Participants (n=925) up to 1 year of age entering their first RSV season were randomized to receive a single intramuscular injection of nirsevimab or palivizumab (50 mg if <5 kg or 100 mg if >5 kg body weight). Safety was assessed by monitoring the occurrence of treatment-emergent adverse events or treatment-emergent serious adverse events through 360 days post-dose. Serum levels of nirsevimab following dosing (on day 151) in this trial were comparable with those observed in the MELODY study, suggesting a similar protection in this population to that in the healthy term and late preterm infants.

Interested in more information about approved antibody therapeutics? Explore our searchable table of antibody therapeutic products for details.

Tezspire (tezepelumab) approved in the European Union for severe asthma

by

On September 19, 2022, the European Commission (EC) approved AstraZeneca’s Tezspire (tezepelumab) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product in the European Union.

The EC’s approval was based on results from the PATHFINDER clinical trial program, which included the placebo-controlled NAVIGATOR Phase 3 trial (NCT03347279), which evaluated the effects of tezepelumab in adults and adolescents with severe uncontrolled asthma. In this study, patients received tezepelumab (210 mg; n=529) or placebo (n=532) SC every 4 weeks for 52 weeks. Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy in this study. For the tezepelumab group, the annualized rate of asthma exacerbations was 0.93 (95% CI, 0.80 to 1.07), while the rate was 2.10 (95% CI, 1.84 to 2.39) with placebo (rate ratio, 0.44; 95% CI, 0.37 to 0.53; P<0.001). Overall, data from the study indicated that, compared to those administered placebo, patients who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life. Full results of the NAVIGATOR trial were published in The New England Journal of Medicine in May 2021.

Tezspire has been approved in the US and other countries for the treatment of severe asthma.

Interested in more information about approved antibody therapeutics? Explore our searchable table of antibody therapeutic products for details.

TECVAYLI® (teclistamab) approved in the European Union

by

On August 24, 2022, The Janssen Pharmaceutical Companies of Johnson & Johnson announced the first approval worldwide for TECVAYLI® (teclistamab) by the European Commission, which granted conditional marketing authorization (CMA) of TECVAYLI® as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Teclistamab (JNJ-64007957) is an IgG4l T-cell redirecting antibody derived from Ligand’s transgenic mouse (OmniAb) and Genmab’s DuoBody technology. The antibody selectively targets BCMA and CD3. Teclistamab was granted the European Medicines Agency’s PRIME designation for treatment of adult patients with relapsed or refractory MM who previously received ≥3 prior lines of therapy in 2021. Teclistamab had previously been granted Orphan Drug designations for MM in both the US and EU, and FDA granted Breakthrough Therapy designation to teclistamab for the treatment of relapsed or refractory MM.

The CMA was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165). In the MajesTEC-1 study, treatment with teclistamab resulted in deep and durable responses. The median duration of progression-free survival and the median duration of overall survival were 11.3 months (95 percent CI; range, 8.8–17.1) and 18.3 months (95 percent CI; range, 15.1–not estimable), respectively.

Janssen submitted a biologics license application to the US Food and Drug Administration seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma in December 2021.

Data for all approved antibody therapeutics can be found here.

European Commission approves Lunsumio for people with relapsed or refractory follicular lymphoma

by

On June 8, 2022, Roche announced that the European Commission granted conditional marketing authorization for Lunsumio® (mosunetuzumab), a T-cell engaging bispecific antibody that targets CD20 and CD3, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. Mosunetuzumab (RG7828, BTCT4465A) is an aglycosylated (N297G) humanized IgG1k bispecific antibody constructed using knobs-into-holes technology.

The approval is based on positive results from the Phase I/II GO29781 study (NCT02500407) in which Lunsumio demonstrated high complete response rates, with the majority of complete responders maintaining responses for at least 18 months, and favorable tolerability in people with heavily pre-treated FL. After a median follow-up of 18.3 months, the median duration of response among responders was 22.8 months (95% CI: 9.7-not estimable), the complete response rate was 60% (n=54/90), the objective response rate was 80% (n=72/90). Lunsumio is currently being evaluated in two Phase 3 studies: CELESTIMO, investigating Lunsumio plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating Lunsumio plus Polivy® (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma.