Soleno Therapeutics Announces Regulatory Update on DCCR (diazoxide choline) Extended-Release Tablets to Treat Prader-Willi Syndrome
Soleno Therapeutics (NASDAQ: SLNO) has received a regulatory update from the FDA regarding its New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets to treat Prader-Willi syndrome (PWS). The FDA Review Division has determined that an advisory committee meeting does not appear necessary at this time. However, the review team will continue to consider this possibility during their ongoing evaluation.
The DCCR NDA has been designated for Priority Review with a PDUFA target action date of December 27, 2024. Soleno Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases.
Soleno Therapeutics (NASDAQ: SLNO) ha ricevuto un aggiornamento normativo dalla FDA riguardo alla sua Richiesta di Nuovo Farmaco (NDA) per le compresse a rilascio prolungato di DCCR (diazoxide colina) destinate al trattamento della sindrome di Prader-Willi (PWS). La Divisione di Revisione della FDA ha stabilito che al momento non sembra necessaria una riunione del comitato consultivo. Tuttavia, il team di revisione continuerà a prendere in considerazione questa possibilità durante la loro valutazione in corso.
La NDA per il DCCR è stata designata per una Revisione Prioritaria con una data target di azione PDUFA fissata al 27 dicembre 2024. Soleno Therapeutics è un'azienda biofarmaceutica in fase clinica focalizzata nello sviluppo di terapie innovative per malattie rare.
Soleno Therapeutics (NASDAQ: SLNO) ha recibido una actualización regulatoria de la FDA respecto a su Solicitud de Nuevo Medicamento (NDA) para las tabletas de liberación prolongada de DCCR (diazóxido colina), destinadas al tratamiento del sindrome de Prader-Willi (PWS). La División de Revisión de la FDA ha determinado que no parece necesario, en este momento, una reunión del comité asesor. Sin embargo, el equipo de revisión seguirá considerando esta posibilidad durante su evaluación en curso.
La NDA de DCCR ha sido designada para Revisión Prioritaria con una fecha objetivo de acción PDUFA del 27 de diciembre de 2024. Soleno Therapeutics es una empresa biofarmacéutica en etapa clínica centrada en el desarrollo de terapias novedosas para enfermedades raras.
솔레노 제약 (NASDAQ: SLNO)는 프라더-윌리 증후군(PWS) 치료를 위한 DCCR(디지옥사이드 콜린) 장기 방출 정제의 신약 신청(NDA)에 대한 FDA의 규제 업데이트를 받았습니다. FDA 검토 부서는 현재로서는 자문 위원회 회의가 필요하지 않다고 판단했습니다. 그러나, 검토팀은 ongoing 평가 동안 이 가능성을 계속 고려할 것입니다.
DCCR NDA는 우선 검토로 지정되었으며, PDUFA 목표 행동 날짜는 2024년 12월 27일입니다. 솔레노 제약은 희귀 질환을 위한 혁신적인 치료제를 개발하는 데 중점을 둔 임상 단계의 생명공학 회사입니다.
Soleno Therapeutics (NASDAQ: SLNO) a reçu une mise à jour réglementaire de la FDA concernant sa Demande de Nouveau Médicament (NDA) pour des comprimés à libération prolongée de DCCR (diazoxide choline) destinés à traiter le syndrome de Prader-Willi (PWS). La division de révision de la FDA a déterminé qu'une réunion du comité consultatif ne semble pas nécessaire pour l'instant. Cependant, l'équipe de révision continuera à envisager cette possibilité lors de leur évaluation en cours.
La NDA pour DCCR a été désignée pour une Examen de Priorité avec une date limite d'action PDUFA au 27 décembre 2024. Soleno Therapeutics est une entreprise biopharmaceutique en phase clinique axée sur le développement de thérapies innovantes pour les maladies rares.
Soleno Therapeutics (NASDAQ: SLNO) hat ein regulatorisches Update von der FDA bezüglich seines Antrags auf ein neues Medikament (NDA) für DCCR (Diazoxid-Cholin) in Form von Tabletten zur Behandlung des Prader-Willi-Syndroms (PWS) erhalten. Die Überprüfungsabteilung der FDA hat festgestellt, dass ein Treffen des Beratungsausschusses zurzeit nicht erforderlich zu sein scheint. Das Überprüfungsteam wird jedoch weiterhin diese Möglichkeit während ihrer laufenden Bewertung in Betracht ziehen.
Der NDA für DCCR wurde für eine Prioritätsprüfung mit einem PDUFA-Zieltermin für die Maßnahme am 27. Dezember 2024 eingestuft. Soleno Therapeutics ist ein biopharmazeutisches Unternehmen in der klinischen Phase, das sich auf die Entwicklung neuartiger Therapeutika für seltene Krankheiten spezialisiert hat.
- FDA Review Division currently sees no need for an advisory committee meeting
- NDA for DCCR has been granted Priority Review status
- PDUFA target action date set for December 27, 2024
- None.
Insights
This regulatory update from the FDA regarding DCCR for Prader-Willi syndrome is a positive development for Soleno Therapeutics. The FDA's decision not to require an advisory committee meeting at this time suggests confidence in the data submitted. This could potentially streamline the approval process, although it's important to note that the FDA may still call for a meeting later if deemed necessary.
The Priority Review designation with a PDUFA date of December 27, 2024, is particularly significant. Priority Review is granted to drugs that, if approved, would provide significant improvements in the safety or effectiveness of treating serious conditions. This expedited review process reduces the standard review time from 10 months to 6 months, indicating the FDA's recognition of DCCR's potential importance in treating PWS.
For investors, this update suggests a potentially faster path to market for DCCR, which could translate to earlier revenue generation if approved. However, it's important to remember that FDA decisions are never guaranteed and the review process is ongoing. The market will likely watch closely for any further updates as the PDUFA date approaches.
REDWOOD CITY, Calif., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced a regulatory update from the U.S. Food and Drug Administration (FDA).
The FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS). However, the Division’s review team will continue to consider the potential need for an advisory committee meeting during their ongoing review.
As announced previously, the DCCR NDA was designated for Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024.
About PWS
The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening condition characterized by feelings of intense, persistent hunger, food pre-occupation, and an extreme drive to seek and consume food, which can severely diminish the quality of life for individuals with PWS and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease. In a global survey conducted by the Foundation for Prader-Willi Research,
About DCCR (Diazoxide Choline) Extended-Release Tablets
DCCR is a novel, proprietary extended-release dosage form containing diazoxide choline, the crystalline salt of diazoxide and is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of individuals in a few rare diseases in neonates, infants, children and adults, but is not approved for use in PWS. Soleno conceived of and established extensive patent protection for the therapeutic use of diazoxide, diazoxide choline and DCCR in individuals with PWS. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, one of which was in individuals with PWS. In the PWS Phase 3 clinical development program, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters.
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. An NDA for its lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS) is currently under review by the FDA and was granted Priority Review. For more information, please visit www.soleno.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with the FDA’s review of our NDA, market conditions, as well as risks and uncertainties inherent in Soleno’s business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
FAQ
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