Rosebery, N.S.W., Dec. 8, 2021 /Medianet/ —
- RegkironaTM (regdanvimab) is a new monoclonal antibody treatment for adults with COVID-19 who do not require supplemental oxygen and are at increased risk of their disease becoming severe
- In Australia, there is a significant need for additional treatments to protect vulnerable Australians at risk of developing severe COVID-19 as new variants arrive
- The therapy has also been approved by the European Commission, granted regulatory approval in Korea, emergency use authorisation in Indonesia and Brazil, and conditional approval in Peru
Sydney, December 8th, 2021 – Celltrion Healthcare Australia Pty Ltd is pleased to confirm that Therapeutic Goods Administration (TGA) has granted provisional approval of Regkirona (regdanvimab), a monoclonal antibody for the treatment of mild-to-moderate COVID-19 in adults infected with SARS-CoV-2.1
Regkirona is administered as a single intravenous infusion in a hospital setting to prevent serious outcomes associated with COVID-19. It works by binding to a specific target on the SARs-CoV-2 virus – the spike receptor binding protein – and flags it as ‘foreign’ so that other parts of the immune system can help clear it away.
To date, Regkirona has received marketing authorisation by the European Medicines Agency (EMA). It has also been granted regulatory approval in the Republic of Korea and emergency use authorisations in Indonesia, Brazil and conditional approval in Peru.
“The announcement today is a significant step forward for Australia’s response to COVID-19, particularly in the hospital setting where resources remain in demand. Although Australia’s vaccination rates are increasing, emerging new strains are indicating the need to remain vigilant and on the front foot with treatment options in our ongoing medical response to the pandemic,” states Associate Professor Paul Griffin, practicing infectious diseases physician and clinical microbiologist at the University of Queensland. “Regkirona offers an option for those at high-risk of progressing to severe COVID-19, especially in cases where possible drug-drug interactions need to be considered.”
“Today’s announcement underscores our ongoing commitment to addressing the world’s greatest health challenges and represents significant part of Celltrion Healthcare’s commitment to providing more options to patients, and more specifically our commitment to the COVID-19 pandemic,” said Cecilia Sung, Country Manager, Australia and New Zealand.
“As part of our global efforts to accelerate access to this treatment, we have been communicating with a number of governments across the world, including Australia. Celltrion will continue working with all stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments,” she added.
Celltrion recognise the critical importance for new treatments in Australia to prevent serious outcomes associated with COVID-19, and are committed to bringing Regkirona to Australian patients as quickly as possible.
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Contacts:
Issued on behalf of Celltrion Healthcare Australia by Cube
For further information please contact:
Anne-Marie Sparrow on 0417 421 560 or Nicole Birch on 0423 916 330
Reference
1.Australian Government Department of Health. Therapeutic Goods Administration:https://www.tga.gov.au/media-release/tga-provisional-approval-celltrion-healthcare-australia-pty-ltd-covid-19-treatment-regdanvimab-regkirona
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. About Regkirona (regdanvimab) Regkirona was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre- clinical studies showed that Regkirona strongly binds to SARS-CoV-2 RBD and significantly neutralises the wild type and mutant variants of concern. In in vivo models, Regkirona effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global phase I and phase II/III clinical trials of Regkirona demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild-to-moderate symptoms of COVID-19. The EC granted marketing authorisation for Celltrion’s Regkirona following positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2021. PBS Information: This product is not listed on the PBS
Minimum Product Information
Before prescribing, please review full product information available on request from the Celltrion Healthcare Medical Information Service (Phone: 1800 325 228) or via www.ebs.tga.gov.au.
REGKIRONA® contains the active ingredient regdanvimab (rch).
INDICATIONS. REGKIRONA has provisional approval for the treatment of adults with coronavirus disease 2019 (COVID-19)who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19. The decisionhas been made on the basis of short-term efficacy and safety data. Continued approval of this indication depends on theevidence of longer-term efficacy and safety from assessment. CONTRAINDICATIONS. Hypersensitivity to the activesubstance or any of the excipients. PRECAUTIONS. Hypersensitivity: Serious hypersensitivity reactions, includinganaphylaxis, have been reported with administration of regdanvimab. If signs and symptoms of a clinically significanthypersensitivity reaction or anaphylaxis occur, administration of regdanvimab should be discontinued and appropriatesupportive treatment should be administered. Infusion-Related Reactions: Infusion-related reactions have been observedwith administration of regdanvimab. If an infusion-related reaction occurs, slowing or stopping the infusion should beconsidered and appropriate medicinal products and/or supportive care should be administered. Antiviral Resistance: Theclinical trials with regdanvimab were conducted in subjects who were predominantly infected with the wild-type virus and theAlpha (UK origin/B.1.1.7 lineage) variant. Healthcare professionals should consider the prevalence of SARS-CoV-2 variantsin their area, where data are available, when considering treatment options. Use in the Elderly: No age-dependent trendswere observed in the pharmacokinetics, efficacy and safety of patients with mild-to-moderate COVID-19 aged 65 or oldercompared to younger patients based on subgroup analyses in an ambulatory (non-hospitalised) clinical trial. PaediatricUse: The safety and efficacy of regdanvimab have not been established in children. INTERACTIONS. No pharmacokineticor pharmacodynamic interactions studies have been performed with regdanvimab. The efficacy and safety of regdanvimabin subjects who have received a COVID-19 vaccine has not been established. ADVERSE EFFECTS. The most frequentlyreported adverse reaction (≥3% of patients) in 906 subjects exposed to regdanvimab in clinical trials washypertriglyceridaemia (4.2% of regdanvimab-treated patients and 4.6% of placebo-treated patients). Treatment-emergentserious adverse events (TESAEs) were reported in 4 regdanvimab-treated patients (0.5%) and 1 placebo-treated patient(0.1%). Infusion-related reactions were the only TESAEs considered to be related to study treatment (1 [0.1%] patient, Grade2)in the regdanvimab treatment group. DOSAGE AND ADMINISTRATION. As part of risk stratification of patients thepivotal consideration is the comorbidities, alongside age, particularly multiple comorbidities. REGKIRONA should not beused in patients hospitalised due to COVID-19. REGKIRONA should be administered after a positive viral test for SARS-CoV-2 and within 7 days of symptom onset. The recommended dosage of REGKIRONA in adults is a single intravenousinfusion of 40 mg/kg. The maximum dosage of REGKIRONA should not exceed 8,000 mg. Infusion instructions: Forintravenous use only. See full PI.