Novaremed ontvangt Fast Track-aanwijzing van de FDA voor NRD135S.E1 voor de behandeling van pijnlijke diabetische perifere neuropathie
BASEL, Zwitserland – (BUSINESS WIRE) – Novaremed AG (Novaremed), een Zwitsers biofarmaceutisch bedrijf in klinische fase, heeft vandaag aangekondigd dat het Fast Track Designation (FTD) heeft ontvangen van de Amerikaanse Food and Drug Administration (FDA) voor de ontwikkeling van NRD135S .E1 voor de behandeling van pijnlijke diabetische perifere neuropathie (PDPN).
Door Fast Track Designation toe te kennen aan NRD135S.E1, een kandidaat-onderzoeker voor de behandeling van PDPN, heeft de FDA het potentieel erkend om de resultaten voor patiënten met deze slopende ziekte op betekenisvolle wijze te verbeteren. Dit is een uitstekende erkenning, aangezien we van plan zijn onze Fase 2b-studie te starten ”, aldus Sara Mangialaio, MD, PhD, hoofd van R&D en CMO van Novaremed. “FTD is ontworpen om de ontwikkeling te vergemakkelijken en de beoordeling te versnellen van onderzoeksbehandelingen die het potentieel aantonen om in onvervulde medische behoeften in ernstige omstandigheden te voorzien.”
Novaremed Receives Fast Track Designation from the FDA for NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy
BASEL, Switzerland–(BUSINESS WIRE)– Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, announced today that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the development of NRD135S.E1 for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN).
“By awarding Fast Track Designation to NRD135S.E1, an investigational candidate for the treatment of PDPN, the FDA has recognized its potential to meaningfully improve outcomes for patients with this debilitating disease. This is an excellent acknowledgement as we plan to initiate our Phase 2b study,” said Sara Mangialaio, MD, PhD, Head of R&D and CMO of Novaremed. “FTD is designed to facilitate the development and expedite the review of investigational treatments that demonstrate the potential to address unmet medical needs in serious conditions.”
About Fast Track Designation
Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses. Fast Track Designation can lead to an Accelerated Approval and Priority Review, if certain criteria are met.
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About Novaremed
Novaremed Ltd, a wholly owned subsidiary of Novaremed AG was founded in 2008 in Israel and Novaremed AG was founded in 2017 in Switzerland. Novaremed Ltd is developing NRD135S.E1, an orally active non-opioid small molecule with a novel mechanism of action against PDPN. In a Phase 2a Proof of Concept study, NRD135S.E1 showed clinically relevant reduction in patient-reported pain and an excellent safety and tolerability profile. Novaremed Ltd is currently preparing to conduct a Phase 2b study in PDPN patients in USA.
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Contacts
For further information about Novaremed, please contact:
Subhasis Roy, CEO/COO
Tel: +41 79 2075715