AEON Biopharma Announces Positive Outcome from FDA Biosimilar Advisory Meeting
AEON Biopharma (NYSE: AEON) announced a positive outcome from its FDA Biosimilar Advisory Meeting for ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX庐 (onabotulinumtoxinA). The company is aligned with the FDA on the 351(k) regulatory pathway for approval. Key points include:
1. Comparative analytical studies are expected to start in Q4 2024.
2. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to review results and confirm the proposed study package.
3. AEON aims to bring prabotulinumtoxinA to the U.S. market for all of BOTOX's approved and future therapeutic indications under a single approval.
4. The company anticipates conducting a Phase 3 program, subject to funding, to compare ABP-450 with BOTOX庐.
AEON Biopharma (NYSE: AEON) ha annunciato un esito positivo dal suo incontro consultivo con l'FDA riguardo all'ABP-450 (prabotulinumtoxinA) come biosimilare di BOTOX庐 (onabotulinumtoxinA). L'azienda 猫 in linea con l'FDA sul percorso normativo 351(k) per l'approvazione. I punti chiave includono:
1. Gli studi analitici comparativi dovrebbero iniziare nel Q4 2024.
2. 脠 previsto un incontro di tipo 2 sulla Sviluppo di Prodotti Biologici Biosimilari (BPD) con l'FDA per 2025 per rivedere i risultati e confermare il pacchetto di studio proposto.
3. AEON punta a portare prabotulinumtoxinA nel mercato statunitense per tutte le indicazioni terapeutiche approvate e future di BOTOX con un'unica approvazione.
4. L'azienda prevede di condurre un programma di Fase 3, soggetto a finanziamento, per confrontare ABP-450 con BOTOX庐.
AEON Biopharma (NYSE: AEON) anunci贸 un resultado positivo de su reuni贸n consultiva con la FDA sobre el ABP-450 (prabotulinumtoxinA) como biosimilar de BOTOX庐 (onabotulinumtoxinA). La compa帽铆a est谩 alineada con la FDA en la v铆a regulatoria 351(k) para la aprobaci贸n. Los puntos clave incluyen:
1. Se espera que los estudios anal铆ticos comparativos comiencen en Q4 2024.
2. Est谩 planeada una reuni贸n de tipo 2 sobre el Desarrollo de Productos Biol贸gicos Biosimilares (BPD) con la FDA para 2025 para revisar los resultados y confirmar el paquete de estudio propuesto.
3. AEON tiene como objetivo llevar prabotulinumtoxinA al mercado de EE. UU. para todas las indicaciones terap茅uticas aprobadas y futuras de BOTOX bajo una 煤nica aprobaci贸n.
4. La compa帽铆a anticipa llevar a cabo un programa de Fase 3, sujeto a financiamiento, para comparar ABP-450 con BOTOX庐.
AEON Biopharma (NYSE: AEON)電� ABP-450 (prabotulinumtoxinA)毳� BOTOX庐 (onabotulinumtoxinA)鞚� 氚旍澊鞓れ嫓氚�霟 臧勳＜頃橃棳 FDA 鞛愲 須岇潣鞐愳劀 旮嶌爼鞝侅澑 瓴瓣臣毳� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� 鞀轨澑鞚� 鞙勴暅 FDA鞕� 351(k) 攴滌牅 瓴诫鞐� 毵烄稊鞏� 鞗�歆侅澊瓿� 鞛堨姷雼堧嫟. 欤检殧 雮挫毄鞚� 雼れ潓瓿� 臧欖姷雼堧嫟:
1. 牍勱祼 攵勳劃 鞐瓣惮電� 2024雲� 4攵勱赴鞐� 鞁滌瀾霅� 鞓堨爼鞛呺媹雼�.
2. FDA鞕�鞚� 氚旍澊鞓れ嫓氚�霟� 靸濍頃欖爜 鞝滍拡 臧滊皽(BPD) type 2 須岇潣臧� 2025云�鞐� 瓿勴殟霅橃柎 鞛堨溂氅� 瓴瓣臣毳� 瓴�韱犿晿瓿� 鞝滌晥霅� 鞐瓣惮 韺偆歆�毳� 頇曥澑頃� 鞓堨爼鞛呺媹雼�.
3. AEON鞚� 氇摖 BOTOX鞚� 鞀轨澑霅� 氚� 頄ロ泟 旃橂 鞝侅潙歃濎棎 雽�頃� 雼澕 鞀轨澑鞚� 韱淀暣 prabotulinumtoxinA毳� 氙戈淡 鞁滌灔鞐� 於滌嫓頃� 瓿勴殟鞛呺媹雼�.
4. 須岇偓電� 鞛愱笀 臁半嫭鞚� 臁瓣贝鞚� Phase 3 頂勲攴鸽灗鞚� 靾橅枆頃橃棳 ABP-450瓿� BOTOX庐毳� 牍勱祼頃� 瓴冹溂搿� 鞓堨儊頃橁碃 鞛堨姷雼堧嫟.
AEON Biopharma (NYSE: AEON) a annonc茅 un r茅sultat positif de sa r茅union consultative avec la FDA concernant l'ABP-450 (prabotulinumtoxinA) en tant que biosimilaire du BOTOX庐 (onabotulinumtoxinA). L'entreprise est align茅e avec la FDA sur la voie r茅glementaire 351(k) pour l'approbation. Les points cl茅s incluent :
1. Les 茅tudes analytiques comparatives devraient d茅buter au T4 2024.
2. Une r茅union de type 2 sur le D茅veloppement de Produits Biologiques Biosimilaires (BPD) avec la FDA est pr茅vue pour 2025 afin d'examiner les r茅sultats et de confirmer le paquet d'茅tude propos茅.
3. AEON vise 脿 introduire le prabotulinumtoxinA sur le march茅 am茅ricain pour toutes les indications th茅rapeutiques approuv茅es et futures de BOTOX sous une seule approbation.
4. L'entreprise pr茅voit de mener un programme de Phase 3, sous r茅serve de financement, pour comparer l'ABP-450 avec le BOTOX庐.
AEON Biopharma (NYSE: AEON) hat ein positives Ergebnis aus dem FDA-Biosimilar-Beratungstreffen f眉r ABP-450 (prabotulinumtoxinA) als Biosimilar zu BOTOX庐 (onabotulinumtoxinA) bekannt gegeben. Das Unternehmen ist mit der FDA beim regulatorischen Weg 351(k) abgestimmt f眉r die Genehmigung. Wichtige Punkte sind:
1. Vergleichende analytische Studien sollen im Q4 2024 beginnen.
2. Ein Biosimilar Biological Product Development (BPD) Typ 2 Treffen mit der FDA ist f眉r 2025 geplant, um die Ergebnisse zu 眉berpr眉fen und das vorgeschlagene Studienpaket zu best盲tigen.
3. AEON plant, prabotulinumtoxinA f眉r alle genehmigten und zuk眉nftigen therapeutischen Indikationen von BOTOX auf den US-Markt zu bringen, unter einer einzigen Genehmigung.
4. Das Unternehmen beabsichtigt, ein Phase 3-Programm durchzuf眉hren, das von der Finanzierung abh盲ngt, um ABP-450 mit BOTOX庐 zu vergleichen.
- Alignment with FDA on 351(k) regulatory pathway for ABP-450 biosimilar approval
- Clear development path established with comparative analytical studies starting Q4 2024
- Potential for single approval covering all BOTOX's current and future therapeutic indications
- Opportunity to enter the U.S. market with a biosimilar to a well-established product (BOTOX)
- Need for additional funding to conduct required Phase 3 program
- Uncertainty regarding the necessity of comparative clinical studies pending FDA review of analytical assessment
- Extended timeline for potential market entry, with key meetings and studies planned through 2025
Insights
This news is highly significant for AEON Biopharma and the broader botulinum toxin market. The FDA's alignment on the 351(k) biosimilar pathway for ABP-450 could potentially streamline the approval process, reducing time and costs compared to a traditional new drug application. Key points:
- Comparative analytical studies planned for Q4 2024 are important for demonstrating biosimilarity to BOTOX®
- The 2025 BPD Type 2 meeting will be pivotal in determining the extent of clinical trials required
- If successful, this approach could allow AEON to target all of BOTOX's approved indications with a single approval
This strategy could significantly expand AEON's market potential, as BOTOX® generated over
The FDA's receptiveness to AEON's 351(k) biosimilar approach for ABP-450 is a positive regulatory signal. Key regulatory considerations:
- The 351(k) pathway can be faster and less costly than traditional approval routes
- Comparative Analytical Assessment (CAA) is crucial; positive results could reduce clinical trial requirements
- The FDA's flexibility on clinical studies post-CAA is noteworthy, potentially saving significant resources
However, challenges remain. The company must demonstrate high analytical similarity to BOTOX®, a complex biological product. Any discrepancies could lead to more extensive clinical trial requirements. The 2025 BPD Type 2 meeting will be critical in determining the regulatory path forward. While promising, investors should be aware that biosimilar development still carries regulatory risks and uncertainties.
鈥� Company is aligned with the FDA on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX庐 (onabotulinumtoxinA) as the reference product聽鈥�
鈥� Comparative analytical studies anticipated to commence in Q4 2024聽鈥�
鈥� Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to review the results from the analytical studies and confirm remainder of proposed study package 鈥�
IRVINE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (鈥淎EON鈥� or the 鈥淐ompany鈥�) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the U.S. Food and Drug Administration (FDA) for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX庐 (onabotulinumtoxinA) as the reference product. The purpose of the meeting was to seek alignment with the FDA on proposed 351(k) regulatory pathway and determine the next steps in the development pathway.
The Company believes it is aligned with the FDA on key requirements, including additional analytical studies to be completed to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). The Company is actively planning comparative analytical studies, which are expected to commence in Q4 2024. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to discuss the outcome from these studies and determine the next steps in development, including a potential comparative clinical program.
鈥淲e are encouraged by the outcome from the recent FDA meeting and the opportunity to advance our development of prabotulinumtoxinA utilizing the 351(k) biosimilar regulatory pathway,鈥� commented Marc Forth, AEON鈥檚 President and Chief Executive Officer. 鈥淲e now have a clear path forward and plan to initiate analytical studies in Q4 2024. This biosimilar approach could potentially allow us to bring prabotulinumtoxinA to the U.S. market for all of BOTOX鈥檚 currently approved and future therapeutic indications under a single approval.鈥�
As previously announced, the Company expects it will need to conduct, subject to securing funding, a Phase 3 program to compare ABP-450 (prabotulinumtoxinA) with BOTOX庐 (onabotulinumtoxinA) as the reference product. Under the 351(k) regulatory framework, comparative clinical studies are only required when it is necessary to address any residual uncertainty regarding biosimilarity following a comparative analytical assessment (CAA). The necessity of any specific comparative clinical studies will be determined after the FDA has reviewed the results from the CAA, which AEON currently anticipates in 2025.
About AEON Biopharma
AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit .
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON鈥檚 future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of analytical studies and a potential Phase 3 comparative program, the securing of additional funding, the translation of clinical trial results into support for a BLA filing, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON鈥檚 future capital requirements; (iii) AEON鈥檚 ability to raise financing in the future; (iv) AEON鈥檚 ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled 鈥淩isk Factors鈥� and 鈥淐autionary Note Regarding Forward-Looking Statements鈥� in the Company鈥檚 filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC鈥檚 website at .
Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.
Source: AEON Biopharma
FAQ
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