Ryoncil® Product Information Now Available in All Four Major Drug Pricing Compendia in United States
Mesoblast (Nasdaq:MESO; ASX:MSB) announced that pricing information for Ryoncil® is now accessible in all four major U.S. drug pricing compendia. This development follows the FDA's approval and publication of the revised Ryoncil® label, specifically updating Section 16 regarding supply and handling information.
The update includes the approval of eight new Ryoncil® kits, each with unique National Drug Codes (NDC), designed to match product dosage with patient weight-bands. Treatment centers can now order weight-appropriate kits with uniform pricing regardless of patient weight. The four major compendia are Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database, and Wolters Kluwer Medi-Span® Price Rx®.
Mesoblast (Nasdaq:MESO; ASX:MSB) ha annunciato che le informazioni sui prezzi per Ryoncil® sono ora accessibili in tutti e quattro i principali compendi di prezzo dei farmaci negli Stati Uniti. Questo sviluppo segue l'approvazione e la pubblicazione da parte della FDA dell'etichetta aggiornata di Ryoncil®, in particolare l'aggiornamento della Sezione 16 riguardante le informazioni su fornitura e gestione.
L'aggiornamento include l'approvazione di otto nuovi kit di Ryoncil®, ognuno con codici nazionali unici (NDC), progettati per abbinare il dosaggio del prodotto con i gruppi di peso dei pazienti. I centri di trattamento possono ora ordinare kit appropriati per il peso con prezzi uniformi indipendentemente dal peso del paziente. I quattro principali compendi sono Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database e Wolters Kluwer Medi-Span® Price Rx®.
Mesoblast (Nasdaq:MESO; ASX:MSB) anunció que la información de precios para Ryoncil® ahora está disponible en los cuatro principales compendios de precios de medicamentos de EE. UU. Este desarrollo sigue a la aprobación y publicación por parte de la FDA de la etiqueta revisada de Ryoncil®, específicamente actualizando la Sección 16 sobre información de suministro y manejo.
La actualización incluye la aprobación de ocho nuevos kits de Ryoncil®, cada uno con códigos nacionales únicos (NDC), diseñados para coincidir con la dosis del producto y los grupos de peso de los pacientes. Los centros de tratamiento ahora pueden ordenar kits adecuados para el peso con precios uniformes independientemente del peso del paciente. Los cuatro principales compendios son Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database y Wolters Kluwer Medi-Span® Price Rx®.
Mesoblast (Nasdaq:MESO; ASX:MSB)는 Ryoncil®의 가격 정보가 이제 미국의 네 가지 주요 약물 가격 컴펜디움에서 이용 가능하다고 발표했습니다. 이 개발은 FDA의 승인과 Ryoncil® 라벨의 개정판 발표에 이어 발생했으며, 특히 공급 및 처리 정보에 관한 섹션 16을 업데이트했습니다.
업데이트에는 여덟 개의 새로운 Ryoncil® 키트의 승인이 포함되어 있으며, 각 키트는 고유한 국가 약물 코드(NDC)를 가지고 있어 제품 용량과 환자 체중대에 맞춰 설계되었습니다. 치료 센터는 이제 환자의 체중에 관계없이 균일한 가격으로 적절한 체중 키트를 주문할 수 있습니다. 네 가지 주요 컴펜디움은 Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database 및 Wolters Kluwer Medi-Span® Price Rx®입니다.
Mesoblast (Nasdaq:MESO; ASX:MSB) a annoncé que les informations sur les prix pour Ryoncil® sont désormais accessibles dans les quatre principaux compendiums de prix des médicaments aux États-Unis. Ce développement fait suite à l'approbation par la FDA et à la publication de l'étiquette révisée de Ryoncil®, mettant spécifiquement à jour la section 16 concernant les informations sur l'approvisionnement et la gestion.
La mise à jour inclut l'approbation de huit nouveaux kits Ryoncil®, chacun avec des codes nationaux de médicaments (NDC) uniques, conçus pour correspondre à la posologie du produit avec les groupes de poids des patients. Les centres de traitement peuvent désormais commander des kits appropriés au poids avec des prix uniformes, quel que soit le poids du patient. Les quatre principaux compendiums sont Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database et Wolters Kluwer Medi-Span® Price Rx®.
Mesoblast (Nasdaq:MESO; ASX:MSB) gab bekannt, dass Preisinformationen für Ryoncil® jetzt in allen vier großen US-Arzneimittelpreisverzeichnissen verfügbar sind. Diese Entwicklung folgt der Genehmigung und Veröffentlichung des überarbeiteten Ryoncil®-Labels durch die FDA, insbesondere der Aktualisierung von Abschnitt 16 zu Informationen über Versorgung und Handhabung.
Das Update umfasst die Genehmigung von acht neuen Ryoncil®-Kits, von denen jedes über einzigartige nationale Arzneimittelkodierungen (NDC) verfügt, die darauf ausgelegt sind, die Produktdosierung mit den Gewichtsklassen der Patienten abzugleichen. Behandlungszentren können nun gewichtsangemessene Kits zu einheitlichen Preisen unabhängig vom Gewicht des Patienten bestellen. Die vier großen Verzeichnisse sind Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database und Wolters Kluwer Medi-Span® Price Rx®.
- FDA approval of eight new weight-based Ryoncil kits streamlines ordering process
- Uniform pricing structure regardless of patient weight improves pricing transparency
- Complete integration into all major U.S. drug pricing databases enhances market access
- None.
NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that pricing information for Ryoncil® is now available in all four major drug pricing compendia in the United States. These pricing compendia provide the official source for all information required to order product, including product manufacturing details, National Drug Codes (NDC) for kit purchase, and kit pricing.
The pricing compendia listing followed approval and publication by the U.S. Food and Drug Administration (FDA) of the revised Ryoncil® label, which includes revisions to Section 16 (How Supplied / Storage and Handling) of the product prescribing information. The revisions included acceptance of eight new Ryoncil® kits, each with its own NDC, based on allocation of product dosage according to patient weight-bands. Treatment centers will be able to order kits tailored to the appropriate dosage for each patient, with pricing applied uniformly, regardless of patient weight.
The four compendia comprise Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database, and Wolters Kluwer Medi-Span® Price Rx®.
About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast’s RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.
Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.
About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets.
About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
| Corporate Communications / Investors | Media – Global |
| Paul Hughes | Allison Worldwide |
| T: +61 3 9639 6036 | Emma Neal |
| E: investors@mesoblast.com | T: +1 603 545 4843 |
| E: emma.neal@allisonworldwide.com | |
| Media – Australia | |
| BlueDot Media | |
| Steve Dabkowski | |
| T: +61 419 880 486 | |
| E: steve@bluedot.net.au | |
FAQ
What are the new changes to Ryoncil's product information announced by MESO?
How many new Ryoncil kits did the FDA approve for MESO?
Which drug pricing compendia now include Ryoncil's information?
How will the new Ryoncil kit pricing structure work for MESO customers?
