Calliditas partner STADA receives European Commission decision for full approval of Kinpeygo® for the treatment of IgA Nephropathy
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) announced that the European Commission has granted full marketing authorization for Kinpeygo® to treat adults with primary immunoglobulin A nephropathy (IgAN). This approval significantly broadens the label, now covering patients with urine protein excretion (UPCR) ≥ 0.8g/g, based on the two-year data from the Phase 3 NefIgArd clinical trial. The approval triggers a €10 million milestone payment to Calliditas, recognizable as revenue in Q3. Kinpeygo, marketed exclusively by STADA Arzneimittel AG in the EU and UK, now has orphan drug status with 10-year market exclusivity until 2032.
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ha annunciato che la Commissione Europea ha concesso l'autorizzazione completa alla commercializzazione per Kinpeygo® per trattare adulti affetti da nefropatia da immunoglobulina A primaria (IgAN). Questa approvazione amplia notevolmente l'etichetta, coprendo ora pazienti con un'escrezione di proteine nelle urine (UPCR) ≥ 0,8 g/g, basata sui dati biennali dello studio clinico di Fase 3 NefIgArd. L'approvazione attiva un pagamento di milione di euro 10 a Calliditas, che sarà riconosciuto come ricavo nel terzo trimestre. Kinpeygo, commercializzato esclusivamente da STADA Arzneimittel AG nell'UE e nel Regno Unito, ha ora lo status di farmaco orfano con un'esclusiva di mercato di 10 anni fino al 2032.
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Estocolmo: CALTX) anunció que la Comisión Europea ha otorgado la autorización de comercialización completa para Kinpeygo® para tratar a adultos con nefropatía por inmunoglobulina A primaria (IgAN). Esta aprobación amplía significativamente la etiqueta, ahora cubriendo pacientes con una excreción de proteínas en orina (UPCR) ≥ 0,8 g/g, basada en los datos de dos años del ensayo clínico de Fase 3 NefIgArd. La aprobación activa un pago de hito de 10 millones de euros a Calliditas, que se reconocerá como ingreso en el tercer trimestre. Kinpeygo, comercializado exclusivamente por STADA Arzneimittel AG en la UE y el Reino Unido, ahora tiene el estatus de medicamento huérfano con exclusividad en el mercado durante 10 años hasta 2032.
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq 스톡홀름: CALTX)는 유럽연합 집행위원회가 1형 면역글로불린 A 신병증(IgAN) 성인을 치료하기 위해 Kinpeygo®에 대해 전체 마케팅 승인을 부여했다고 발표했습니다. 이 승인은 이제 0.8g/g 이상의 단백뇨(UPCR)를 가진 환자도 포함되도록 라벨을 크게 확장하며, 이는 3상 NefIgArd 임상 시험의 2년 데이터에 기반합니다. 승인은 Calliditas에게 1천만 유로의 이정표 지급을 발생시키며, 이는 3분기 수익으로 인식됩니다. Kinpeygo는 EU 및 영국에서 STADA Arzneimittel AG에 의해 독점적으로 판매되며, 이제 2032년까지 10년의 시장 독점권을 가진 희귀의약품으로 등록되었습니다.
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) a annoncé que la Commission européenne a accordé l'autorisation de mise sur le marché complète pour Kinpeygo® afin de traiter les adultes atteints de néphropathie à immunoglobuline A primaire (IgAN). Cette approbation élargit considérablement l'étiquetage, couvrant désormais les patients avec une excrétion protéique urinaire (UPCR) ≥ 0,8 g/g, basée sur les données de deux ans de l'essai clinique de Phase 3 NefIgArd. Cette approbation déclenche un paiement d'étape de 10 millions d'euros à Calliditas, reconnaissable en tant que revenu au troisième trimestre. Kinpeygo, commercialisé exclusivement par STADA Arzneimittel AG dans l'UE et le Royaume-Uni, bénéficie désormais du statut de médicament orphelin avec une exclusivité de marché de 10 ans jusqu'en 2032.
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) gab bekannt, dass die Europäische Kommission die vollständige Zulassung für die Vermarktung von Kinpeygo® zur Behandlung von Erwachsenen mit primärer Immunglobulin-A-Nephropathie (IgAN) erteilt hat. Diese Genehmigung erweitert das Label erheblich und umfasst jetzt Patienten mit einer Urin-Proteinausscheidung (UPCR) ≥ 0,8 g/g, basierend auf den zweijährigen Daten der Phase-3-Studie NefIgArd. Die Genehmigung löst eine 10 Millionen Euro Meilensteinzahlung an Calliditas aus, die im dritten Quartal als Umsatz erkennbar ist. Kinpeygo, das exklusiv von STADA Arzneimittel AG in der EU und im Vereinigten Königreich vermarktet wird, hat jetzt den Status eines Orphan-Arztes mit 10 Jahren Marktexklusivität bis 2032.
- Full marketing authorization granted by European Commission for Kinpeygo®
- Expanded label coverage for broader patient population (UPCR ≥ 0.8g/g)
- €10 million milestone payment to be recognized as revenue in Q3
- Orphan drug status with 10-year market exclusivity until 2032
- Positive results from Phase 3 NefIgArd clinical trial published in The Lancet
- None.
Insights
The European Commission's full approval of Kinpeygo for IgA Nephropathy (IgAN) represents a significant milestone in rare kidney disease treatment. This decision expands the drug's accessibility to a broader patient population, now including those with urine protein excretion (UPCR) ≥ 0.8g/g, compared to the previous threshold of > 1.5g/g.
The approval is based on compelling two-year data from the Phase 3 NefIgArd trial, published in The Lancet. Notably, the trial met its eGFR (estimated glomerular filtration rate) endpoint with high statistical significance, indicating Kinpeygo's potential to slow kidney function decline in IgAN patients.
From a medical perspective, this approval is groundbreaking as Kinpeygo becomes the first fully approved medication for IgAN in Europe. This targeted-release formulation of budesonide offers a novel approach to treating this rare kidney disease, potentially changing the treatment landscape and improving patient outcomes.
The orphan drug status granted to Kinpeygo, with 10-year market exclusivity until 2032, underscores the unmet medical need in IgAN and provides Calliditas with a strong market position in this therapeutic area.
The European Commission's full approval of Kinpeygo is a significant financial catalyst for Calliditas Therapeutics. This development triggers an immediate
The expanded label for Kinpeygo is particularly noteworthy from a financial perspective. By broadening the eligible patient population, Calliditas and its partner STADA Arzneimittel AG can potentially capture a larger market share, driving increased sales and revenue growth in the European market.
Moreover, the orphan drug designation and 10-year market exclusivity provide a significant competitive advantage. This protection from competition until 2032 allows Calliditas to maximize the commercial potential of Kinpeygo without immediate threat from generic alternatives.
Investors should note that while this approval is undoubtedly positive, the true financial impact will depend on successful market penetration and adoption rates among nephrologists. The rarity of IgAN may present challenges in patient identification and market size, but also opportunities for premium pricing typical of orphan drugs.
The European Commission has granted a full marketing authorization of Kinpeygo®. The granting of the full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population, defined as UPCR of ≥ 0.8g/g, or proteinuria of ≥1.0 g/g over 24 hours. This expanded label is based on full two-year data set from the Phase 3 NefIgArd clinical trial, published in leading medical journal The Lancet (1).
"This is an important event for patients suffering from IgAN in
Kinpeygo is marketed in in the EU and
The full marketing authorization for Kinpeygo covers the European Union (EU) member states as well as
This approval triggers a milestone payment of
- Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomized phase 3 trial - The Lancet
CONTACT:
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
The information was sent for publication, through the agency of the contact person set out above, on July 26, 2024 at 5:00 p.m. CET.
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SOURCE Calliditas Therapeutics
FAQ
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