FDA approves ozanimod, a drug invented at Scripps Research, for multiple sclerosis

  • Ozanimod is the latest in a series of novel medicines to originate from the laboratories of Scripps Research

LA JOLLA, CA, USA (March 26, 2020) — The U.S. Food and Drug Administration has approved ozanimod, an immune-modulating therapy invented at Scripps Research, for the treatment of adults with relapsing forms of multiple sclerosis. The drug is also in advanced clinical development for adults and children with moderate-to-severe ulcerative colitis and Crohn’s disease.

In patient studies supporting ozanimod’s New Drug Application, those who took the once-daily oral medicine experienced significantly less disease progression–including fewer relapses and preservation of the brain from atrophy–than those who received standard care, with very few side effects. The drug, licensed to Bristol Myers Squibb, will be sold under the trademarked name Zeposia.

„Today’s FDA approval of ozanimod is a celebratory milestone for the multiple sclerosis community, which is in need of new, intelligent drug interventions to help patients control the progression of their disease,“ says Hugh Rosen, MD, PhD, who invented ozanimod along with fellow Scripps Research professor Edward Roberts, PhD, and their laboratory colleagues.

Nearly 1 million people in the United States are living with multiple sclerosis, according to the National MS Society, and approximately 85 percent of those patients are diagnosed with the relapsing forms of the disease that ozanimod is designed to treat.

In multiple sclerosis, the immune system mistakenly attacks myelin sheath, the protective layer that surrounds nerves in the brain. This disrupts the flow of information within the brain and between the brain and body, bringing about symptoms that can range from numbness and bladder issues to vision problems and muscle paralysis.

Ozanimod works by acting on certain types of immune cells called lymphocytes that are centrally involved in the autoimmune attack on myelin sheath. It binds to receptors on the cells‘ surface, keeping them from reaching the brain. As a result, the number of activated lymphocytes is decreased, diminishing the immune attack.

The fundamental discoveries that led to ozanimod were reported by Rosen, Roberts and their Scripps Research colleagues in a series of papers from 2002 to 2008. In 2009, Scripps Research licensed ozanimod to biotechnology startup Receptos, which Celgene purchased in 2015 for $7.2 billion. Celgene was acquired by Bristol Myers Squibb in 2019.

Ozanimod is also being studied as a treatment for forms of inflammatory bowel disease, with late-stage clinical trials underway for ulcerative colitis and Crohn’s disease, for which it is a first-in-class treatment.

The ozanimod approval for multiple sclerosis is the latest in a string of FDA-approved drugs to originate from Scripps Research’s laboratories, following on most recent approval of tafamidis for the rare but often fatal heart disease known ATTR-CM.

Scripps Research also invented drugs that have been brought to market to treat more than a dozen other high-need conditions including arthritis, lupus, respiratory distress syndrome, gastric cancer, metastatic non-small cell lung cancer, hemophilia, anthrax inhalation and neuroblastoma. Additional drugs are in development for more than 10 other conditions, ranging from osteoarthritis to Parkinson’s disease, with several in clinical trials.

„There are hardly any other academic institutions in the world that have the multidisciplinary expertise to discover a new disease-modifying compound and generate clinical data in support of its development,“ Rosen says.

Additional molecules developed by Rosen and Roberts at Scripps Research are currently in phase 2 clinical trials for major depressive disease and anxiety, and in phase 1 studies for treatment of autism.

 

About Scripps Research

Scripps Research is an independent, nonprofit biomedical institute ranked the most influential in the world for its impact on innovation. With campuses in La Jolla, California, and Jupiter, Florida, we are advancing human health through profound discoveries that address pressing medical concerns around the globe. Our drug discovery and development division, Calibr, works hand-in-hand with scientists across disciplines to bring new medicines to patients as quickly and efficiently as possible, while teams at Scripps Research Translational Institute harness genomics, digital medicine and cutting-edge informatics to understand individual health and render more effective healthcare. Scripps Research also trains the next generation of leading scientists at our Skaggs Graduate School, consistently named among the top 10 U.S. programs for chemistry and biological sciences.

 


Scripps Research Institute, 26.03.2020 (tB).

Schlagwörter:

MEDICAL NEWS

New guidance to prevent the tragedy of unrecognized esophageal intubation
Overly restrictive salt intake may worsen outcomes for common form…
COVID-19 vaccines are estimated to have prevanented 20 million deaths…
Novel sleep education learning modules developed for nurse practitioners
Scientists discover how salt in tumours could help diagnose and…

SCHMERZ PAINCARE

Aktuelle Versorgungssituation der Opioidtherapie im Fokus
Individuelle Schmerztherapie mit Opioiden: Patienten im Mittelpunkt
Versorgung verbessern: Deutsche Gesellschaft für Schmerzmedizin fordert die Einführung des…
Pflegeexpertise im Fokus: Schmerzmanagement nach Operationen
Versorgung verbessern: Bundesweite Initiative der Deutschen Gesellschaft für Schmerzmedizin zu…

DIABETES

Menschen mit Diabetes während der Corona-Pandemie unterversorgt? Studie zeigt auffällige…
Suliqua® zur Therapieoptimierung bei unzureichender BOT
„Wissen was bei Diabetes zählt: Gesünder unter 7 PLUS“ gibt…
Kaltplasma bei diabetischem Fußsyndrom wirkt via Wachstumsfaktoren
Typ-1-Diabetes: InRange – auf die Zeit im Zielbereich kommt es…

ERNÄHRUNG

Gesunde Ernährung: „Nicht das Salz und nicht das Fett verteufeln“
Mangelernährung gefährdet den Behandlungserfolg — DGEM: Ernährungsscreening sollte zur klinischen…
Wie eine Diät die Darmflora beeinflusst: Krankenhauskeim spielt wichtige Rolle…
DGEM plädiert für Screening und frühzeitige Aufbautherapie: Stationäre COVID-19-Patienten oft…
Führt eine vegane Ernährungsweise zu einer geringeren Knochengesundheit?

ONKOLOGIE

Nahrungsergänzungsmittel während der Krebstherapie: Es braucht mehr Bewusstsein für mögliche…
Fusobakterien und Krebs
Fortgeschrittenes Zervixkarzinom: Pembrolizumab verlängert Leben
Krebspatienten unter Immuntherapie: Kein Hinweis auf erhöhtes Risiko für schwere…
Aktuelle Kongressdaten zum metastasierten Mammakarzinom und kolorektalen Karzinom sowie Neues…

MULTIPLE SKLEROSE

Multiple Sklerose: Analysen aus Münster erhärten Verdacht gegen das Epstein-Barr-Virus
Aktuelle Daten zu Novartis Ofatumumab und Siponimod bestätigen Vorteil des…
Multiple Sklerose durch das Epstein-Barr-Virus – kommt die MS-Impfung?
Neuer Therapieansatz für Multiple Sklerose und Alzheimer
„Ich messe meine Multiple Sklerose selbst!“ – Digitales Selbstmonitoring der…

PARKINSON

Alexa, bekomme ich Parkinson?
Meilenstein in der Parkinson-Frühdiagnose
Parkinson-Erkrankte besonders stark von Covid-19 betroffen
Gangstörungen durch Kleinhirnschädigung beim atypischen Parkinson-Syndrom
Parkinson-Agenda 2030: Die kommenden 10 Jahre sind für die therapeutische…