FDA Approves Use of Up To Three Tubes of Biofrontera Inc.’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment
The FDA has approved Biofrontera’s sNDA to increase the maximum dosage of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10%, from one to three tubes per treatment. This approval enhances the treatment of actinic keratosis (AK) on the face and scalp using Ameluz®-PDT with the BF-RhodoLED or RhodoLED XL lamp. The decision is based on two Phase 1 safety studies involving 116 patients, which confirmed that the increased dosage maintains safety and efficacy levels. This approval allows healthcare providers to treat larger or multiple areas more effectively, improving convenience for both providers and patients. Biofrontera is working with Medicare and commercial payers to secure reimbursement for this update.
La FDA ha approvato la sNDA di Biofrontera per aumentare il dosaggio massimo di Ameluz® (acido aminolevulinico HCI) Gel Topico, 10%, da uno a tre tubi per trattamento. Questa approvazione migliora il trattamento della cheratosi attinica (AK) sul viso e sul cuoio capelluto utilizzando Ameluz®-PDT con la lampada BF-RhodoLED o RhodoLED XL. La decisione si basa su due studi di sicurezza di Fase 1 che hanno coinvolto 116 pazienti, confermando che il dosaggio aumentato mantiene i livelli di sicurezza ed efficacia. Questa approvazione consente ai fornitori di assistenza sanitaria di trattare aree più ampie o multiple in modo più efficace, migliorando la comodità sia per i fornitori che per i pazienti. Biofrontera sta collaborando con Medicare e i pagatori commerciali per garantire il rimborso per questo aggiornamento.
La FDA ha aprobado la sNDA de Biofrontera para aumentar la dosis máxima de Ameluz® (ácido aminolevulínico HCI) Gel Tópico, 10%, de uno a tres tubos por tratamiento. Esta aprobación mejora el tratamiento de la queratosis actínica (AK) en la cara y el cuero cabelludo utilizando Ameluz®-PDT con la lámpara BF-RhodoLED o RhodoLED XL. La decisión se basa en dos estudios de seguridad de Fase 1 que involucraron a 116 pacientes, los cuales confirmaron que la dosis aumentada mantiene los niveles de seguridad y eficacia. Esta aprobación permite a los proveedores de atención médica tratar áreas más grandes o múltiples de manera más efectiva, mejorando la conveniencia tanto para los proveedores como para los pacientes. Biofrontera está trabajando con Medicare y los pagadores comerciales para asegurar el reembolso para esta actualización.
FDA는 Biofrontera의 sNDA를 승인하여 Ameluz® (아미노레불리닉 산 HCI) 국소젤의 최대 용량을 치료당 하나에서 세 개의 튜브로 늘렸습니다. 이 승인으로 BF-RhodoLED 또는 RhodoLED XL 램프를 사용하여 얼굴과 두피의 광선각화증(AK) 치료가 개선됩니다. 이 결정은 116명의 환자를 포함한 두 개의 1상 안전성 연구에 기반하며, 증가된 용량이 안전성과 효과성을 유지한다고 확인되었습니다. 이 승인은 의료 제공자가 더 크거나 여러 부위를 더 효과적으로 치료할 수 있게 하여, 제공자와 환자 모두의 편의성을 개선합니다. Biofrontera는 이 업데이트에 대한 환급을 확보하기 위해 Medicare 및 상업적 보험사와 협력하고 있습니다.
La FDA a approuvé la sNDA de Biofrontera pour augmenter la dose maximale d'Ameluz® (acide aminolévulinique HCI) Gel Topique, 10%, d'un à trois tubes par traitement. Cette approbation améliore le traitement de la kératose actinique (AK) sur le visage et le cuir chevelu en utilisant Ameluz®-PDT avec la lampe BF-RhodoLED ou RhodoLED XL. La décision est basée sur deux études de sécurité de phase 1 impliquant 116 patients, qui ont confirmé que la dose augmentée maintient les niveaux de sécurité et d'efficacité. Cette approbation permet aux prestataires de soins de santé de traiter plus efficacement des zones plus grandes ou multiples, améliorant ainsi la commodité pour les prestataires et les patients. Biofrontera travaille avec Medicare et les payeurs commerciaux pour garantir le remboursement de cette mise à jour.
Die FDA hat die sNDA von Biofrontera genehmigt, um die maximale Dosis von Ameluz® (Aminolävulinsäure HCI) Topical Gel, 10%, von einem auf drei Tuben pro Behandlung zu erhöhen. Diese Genehmigung verbessert die Behandlung der aktinischen Keratosis (AK) im Gesicht und auf der Kopfhaut mit Ameluz®-PDT unter Verwendung der BF-RhodoLED- oder RhodoLED XL-Lampe. Die Entscheidung basiert auf zwei Phasen-1-Sicherheitsstudien mit 116 Patienten, die bestätigten, dass die erhöhte Dosis die Sicherheits- und Effektivitätsniveaus aufrechterhält. Diese Genehmigung ermöglicht es Gesundheitsdienstleistern, größere oder mehrere Bereiche effektiver zu behandeln, was den Komfort sowohl für Anbieter als auch für Patienten verbessert. Biofrontera arbeitet mit Medicare und kommerziellen Zahlungen zusammen, um eine Erstattung für dieses Update zu sichern.
- FDA approval for increased dosage of Ameluz® enhances treatment flexibility for larger areas of AK.
- Phase 1 safety studies confirmed safety and efficacy with increased dosage.
- Potential for increased revenue as more comprehensive treatment options become available.
- Reimbursement negotiations with Medicare and commercial payers are still pending.
Insights
The FDA's approval for increased dosage of Ameluz® is a significant development for Biofrontera Inc. This expansion allows for treating larger areas of actinic keratosis (AK), potentially increasing the product's market reach and revenue potential. With an estimated 13 million AK treatments annually in the U.S., this approval could substantially boost Ameluz®'s market share.
The approval may lead to:
- Increased revenue per treatment, as up to three tubes can now be used instead of one
- Expanded patient base, as larger treatment areas can be addressed
- Improved competitive positioning against other AK treatments
However, the company still needs to secure reimbursement from Medicare and commercial payers, which is important for widespread adoption. The market's response will depend on how quickly Biofrontera can implement this change and how well it's received by healthcare providers.
For a company with a market cap of
The FDA's approval for using up to three tubes of Ameluz® per treatment is a game-changer in AK management. This expansion addresses a critical need in dermatology practice, allowing for more comprehensive field treatment of actinic keratoses on the face and scalp.
Key clinical implications include:
- Enhanced ability to treat larger affected areas in a single session
- Potential for improved patient outcomes due to more thorough treatment
- Increased convenience for both patients and healthcare providers
The safety profile demonstrated in the Phase I studies is reassuring, showing equivalent adverse events to single-tube use. This maintains Ameluz®'s favorable risk-benefit ratio while expanding its utility.
The approval strengthens Ameluz®'s position as the only FDA-indicated PDT photosensitizer for both lesion-directed and field-directed AK treatment. This versatility, combined with the expanded dosage option, could make Ameluz® a preferred choice for dermatologists managing complex or extensive AK cases.
- Approval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lamp
- Supplemental New Drug Application (sNDA) supported by two Phase 1 safety studies
- AK is the second most common diagnosis made by dermatologists in the United States1
- An estimated 13 million treatments given each year for AK in the US2
WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s sNDA to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment.
This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing photodynamic therapy (PDT) for AK on the face and scalp, leading to greater convenience for both healthcare providers and their patients.
“We are delighted with the FDA’s decision to approve the use of up to three tubes of Ameluz® per treatment,” stated Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. “We are now working with Medicare and commercial payers to obtain reimbursement for this label update and will notify our customers accordingly.”
The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz® were applied to 116 patients. The studies showed that the blood concentrations of the active ingredient and the metabolite were several magnitudes below those at which side effects are known to occur, and that the systemic and application site adverse events were equivalent to those observed with one tube of Ameluz®.
“Ameluz® is the only PDT photosensitizer indicated by the FDA for both lesion-directed and field-directed treatment of AKs. This approval will allow dermatologists to offer the more comprehensive option they desired for their patients, while maintaining the proven efficacy and safety profile of Ameluz®. It is another important milestone for Biofrontera as we continue to demonstrate our commitment to PDT and our dedication to the development of this important treatment modality,” commented Dr. Luebbert.
“Up to
About Actinic Keratosis
AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.3
- Landis ET. et al. Dermatol Online J. 2014 Apr 16;20(4):22368.
- Market data accessible from CMS and IQVIA, 2021
- www.skincancer.org/skin-cancer-information/actinic-keratosis/
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz ® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
Contact:
Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.com
FAQ
What recent approval did Biofrontera receive for Ameluz®?
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