InflaRx Receives European Commission Approval for GOHIBIC® (vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome (ARDS)
InflaRx (NASDAQ: IFRX) has received European Commission marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab), the first approved treatment in the European Union for SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). The approval applies to adult patients receiving systemic corticosteroids and invasive mechanical ventilation, with or without ECMO.
The authorization is supported by Phase 3 PANAMO trial results, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. The approval covers all 27 EU member states plus Iceland, Liechtenstein, and Norway. InflaRx is exploring commercial partnering options in the EU.
In the US, GOHIBIC has received Emergency Use Authorization from the FDA for COVID-19 treatment in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO.
InflaRx (NASDAQ: IFRX) ha ricevuto l'autorizzazione al commercio dalla Commissione Europea in circostanze eccezionali per GOHIBIC® (vilobelimab), il primo trattamento approvato nell'Unione Europea per la sindrome da distress respiratorio acuto (ARDS) indotta da SARS-CoV-2. L'approvazione si applica a pazienti adulti che ricevono corticosteroidi sistemici e ventilazione meccanica invasiva, con o senza ECMO.
L'autorizzazione è supportata dai risultati della fase 3 dello studio PANAMO, che hanno dimostrato una riduzione relativa del 23,9% della mortalità per tutte le cause a 28 giorni rispetto al placebo. L'approvazione copre tutti i 27 stati membri dell'UE più Islanda, Liechtenstein e Norvegia. InflaRx sta esplorando opzioni di collaborazione commerciale nell'UE.
Negli Stati Uniti, GOHIBIC ha ricevuto l'autorizzazione all'uso di emergenza dalla FDA per il trattamento del COVID-19 in adulti ospedalizzati quando iniziato entro 48 ore dall'inizio della ventilazione meccanica invasiva o ECMO.
InflaRx (NASDAQ: IFRX) ha recibido la autorización de comercialización de la Comisión Europea en circunstancias excepcionales para GOHIBIC® (vilobelimab), el primer tratamiento aprobado en la Unión Europea para el síndrome de dificultad respiratoria aguda (ARDS) inducido por SARS-CoV-2. La aprobación se aplica a pacientes adultos que reciben corticosteroides sistémicos y ventilación mecánica invasiva, con o sin ECMO.
La autorización está respaldada por los resultados del ensayo PANAMO de Fase 3, que demostraron una reducción relativa del 23,9% en la mortalidad por todas las causas a 28 días en comparación con el placebo. La aprobación cubre los 27 estados miembros de la UE, así como Islandia, Liechtenstein y Noruega. InflaRx está explorando opciones de asociación comercial en la UE.
En los Estados Unidos, GOHIBIC ha recibido la Autorización de Uso de Emergencia de la FDA para el tratamiento de COVID-19 en adultos hospitalizados cuando se inicia dentro de las 48 horas posteriores a la ventilación mecánica invasiva o ECMO.
인플라Rx (NASDAQ: IFRX)는 GOHIBIC® (빌로벨리맙)에 대해 유럽연합(EU)에서 SARS-CoV-2로 유발된 급성 호흡 곤란 증후군(ARDS)에 대한 첫 번째 승인을 받았습니다. 이 승인은 시스템 스테로이드를 받고 있는 성인 환자, 침습적 기계 환기와 함께 또는 이를 생략한 경우에 해당됩니다.
승인은 플라시보와 비교했을 때 28일 전체 사망률이 23.9% 상대적으로 감소했다는 3상 PANAMO 시험 결과에 의해 뒷받침됩니다. 이 승인은 27개 EU 회원국과 아이슬란드, 리히텐슈타인, 노르웨이를 아우릅니다. 인플라Rx는 EU 내 상업적 파트너십 기회를 모색하고 있습니다.
미국에서는 GOHIBIC가 침대에 있는 성인들에 대한 COVID-19 치료를 위해 FDA로부터 긴급 사용 승인을 받았습니다. 이는 침습적 기계 환기 또는 ECMO를 받은 후 48시간 이내에 시작할 때 가능합니다.
InflaRx (NASDAQ: IFRX) a reçu l'autorisation de mise sur le marché de la Commission européenne dans des circonstances exceptionnelles pour GOHIBIC® (vilobelimab), le premier traitement approuvé dans l'Union européenne pour le syndrome de détresse respiratoire aiguë (SDRA) induit par le SARS-CoV-2. L'approbation s'applique aux patients adultes recevant des corticostéroïdes systémiques et une ventilation mécanique invasive, avec ou sans ECMO.
L'autorisation est soutenue par les résultats de l'essai PANAMO de phase 3, qui ont montré une réduction relative de 23,9 % de la mortalité toutes causes confondues à 28 jours par rapport au placebo. L'approbation couvre les 27 États membres de l'UE ainsi que l'Islande, le Liechtenstein et la Norvège. InflaRx explore des options de partenariat commercial dans l'UE.
Aux États-Unis, GOHIBIC a reçu l'autorisation d'utilisation d'urgence de la FDA pour le traitement du COVID-19 chez les adultes hospitalisés lorsque le traitement est initié dans les 48 heures suivant l'instauration de la ventilation mécanique invasive ou de l'ECMO.
InflaRx (NASDAQ: IFRX) hat von der Europäischen Kommission unter außergewöhnlichen Umständen die Vermarktungsgenehmigung für GOHIBIC® (Vilobelimab) erhalten, die erste genehmigte Behandlung in der Europäischen Union für durch SARS-CoV-2 induziertes akutes Atemnotsyndrom (ARDS). Die Genehmigung gilt für erwachsene Patienten, die systemische Kortikosteroide und invasive mechanische Beatmung erhalten, mit oder ohne ECMO.
Die Genehmigung wird durch die Ergebnisse der Phase-3-Studie PANAMO unterstützt, die eine relative Reduktion der 28-Tage-Mortalität um 23,9 % im Vergleich zur Placebo-Gruppe gezeigt hat. Die Genehmigung gilt für alle 27 Mitgliedstaaten der EU sowie für Island, Liechtenstein und Norwegen. InflaRx untersucht kommerzielle Partnerschaftsmöglichkeiten in der EU.
In den USA hat GOHIBIC von der FDA eine Notfallgenehmigung zur Behandlung von COVID-19 bei hospitalisierten Erwachsenen erhalten, wenn die Behandlung innerhalb von 48 Stunden nach Beginn der invasiven mechanischen Beatmung oder ECMO eingeleitet wird.
- First approved treatment in EU for SARS-CoV-2-induced ARDS
- Phase 3 trial showed 23.9% reduction in 28-day mortality
- Marketing authorization covers 30 European countries
- Emergency Use Authorization already granted in US market
- Marketing authorization granted under 'exceptional circumstances' due to data limitations
- Company still needs commercial partners for EU distribution
- Safety concerns including increased risk of serious infections
- clinical data available for the treatment
Insights
The European Commission's approval of GOHIBIC® (vilobelimab) represents a major regulatory milestone for InflaRx. This is particularly significant as it's the first approved treatment in the EU for SARS-CoV-2-induced ARDS, addressing a critical unmet medical need. The Phase 3 PANAMO trial data showing a
The 'exceptional circumstances' marketing authorization, while reflecting the drug's potential in a rare but severe condition, also indicates some limitations in data collection due to the nature of the disease. The approval spans all 27 EU member states plus Iceland, Liechtenstein and Norway, creating a substantial market opportunity. However, InflaRx's strategy to pursue commercial partnerships rather than direct commercialization suggests a conservative approach to market entry.
The safety profile appears manageable, with most adverse reactions being consistent with the severe nature of COVID-19 ARDS. The existing U.S. Emergency Use Authorization provides additional validation of the treatment's potential.
This EU approval significantly enhances InflaRx's commercial potential, though the impact on immediate financials may be moderate. The company's market cap of
1. The partnership strategy for EU commercialization should help preserve cash reserves while potentially generating licensing revenues and royalties.
2. The 'exceptional circumstances' designation could accelerate market access but might impact pricing and reimbursement negotiations.
3. The company's statement about minimal impact on cash burn rate suggests efficient resource management.
For a small-cap biotech, having two major market approvals (EU and US EUA) for GOHIBIC strengthens the company's negotiating position with potential commercial partners. This could lead to more favorable deal terms and potentially attract larger pharmaceutical companies for partnerships or strategic transactions.
JENA, Germany, Jan. 15, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO). GOHIBIC is the first and only treatment approved in the European Union for the treatment of SARS-CoV-2-induced ARDS.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “The European Commission’s approval of GOHIBIC, the first approval of its kind, reflects our commitment to ICU patients with SARS-CoV-2-induced ARDS, a pressing medical setting in need of more effective therapeutic options. I would like to thank the entire InflaRx team for its dedication and diligence resulting in this successful marketing authorization, and we are grateful for the support provided by the intensive care physicians, patients and their families who participated in the PANAMO study which supported the marketing authorization application.”
The marketing authorization under exceptional circumstances for GOHIBIC is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. InflaRx is considering commercial partnering and distribution options in the EU and does not expect this approach will have a meaningfully negative impact on its cash burn rate.
Important Information about GOHIBIC (vilobelimab)
In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of
A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC’s approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.
In the U.S., GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO. The emergency use of GOHIBIC is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.
GOHIBIC (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using GOHIBIC to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC website http://www.gohibic.com.
Important Safety Information about GOHIBIC (vilobelimab)
There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use.
GOHIBIC has been associated with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.
The most common adverse reactions (incidence ≥
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious AEs or deaths that occur during GOHIBIC treatment and are considered to be potentially attributable to GOHIBIC.
Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de.
For the full prescribing information and additional important safety information, please visit www.GOHIBIC.com.
About Vilobelimab
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response.
Vilobelimab is being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG). Vilobelimab has been granted orphan drug designation for the treatment of PG by both the FDA and the EMA, as well as fast track designation by the FDA.
The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.
About InflaRx
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is also developing INF904, an orally administered small molecule inhibitor of the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.com.
InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
Contacts:
| InflaRx N.V. | MC Services AG |
| Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de | Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752 |
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FAQ
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