Natalizumab is under clinical development by Biogen and currently in Phase II for Graft Versus Host Disease (GVHD). According to GlobalData, Phase II drugs for Graft Versus Host Disease (GVHD) have a 48% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Natalizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Natalizumab (Tysabri) is a recombinant humanized IgG4 monoclonal antibody acts against multiple sclerosis. It is formulated as a solution-concentrate for intravenous and solution for subcutaneous route of administration. Tysabri is indicated as the single disease modifying therapy in highly active relapsing remitting multiple sclerosis, and active secondary progressive disease, in adults.
It is under development for the treatment of graft versus host disease, relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis. It was also under development for the treatment of relapsing multiple sclerosis, rheumatoid arthritis, drug resistant focal epilepsy, relapsed or refractory multiple myeloma, secondary progressive multiple sclerosis and acute ischemic stroke.
It was under development paraneoplastic syndrome.
Biogen is a biopharmaceutical company that discovers, develops, and delivers drugs and biosimilars for the treatment of various neurological and neurodegenerative diseases. The company’s marketed products include Avonex (interferon beta-1a), Vumerity (diroximel fumarate), Tysabri (natalizumab), Tecfidera (dimethyl fumarate), Fampyra (prolonged-release fampridine tablets), and Plegridy (peginterferon beta-1a) for the treatment of multiple sclerosis (MS); Spinraza (nusinersen) for spinal muscular atrophy (SMA); Aduhelm (aducanumab-avwa) for alzheimer’s disease, and Fumaderm (fumaric acid esters) for severe plaque psoriasis. It has several product candidates targeting various indications such as MS, Parkinson’s disease, Lupus, Depression, CNS and neuromuscular disorders, Amyotrophic Lateral Sclerosis, and Alzheimer’s disease. The company sells its products through direct sales force, marketing groups, and distributors in the Americas, Europe, Asia, and other territories. Biogen is headquartered in Cambridge, Massachusetts, the US.
For a complete picture of Natalizumab’s drug-specific PTSR and LoA scores, buy the report here.