Natalizumab is under clinical development by Biogen and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Natalizumab’s likelihood of approval (LoA) and phase transition for Graft Versus Host Disease (GVHD) took place on 26 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Natalizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Natalizumab overview

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 overview

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), 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); and Fumaderm (fumaric acid esters) for severe plaque psoriasis. It has several product candidates targeting various indications such as MS, Parkinson’s disease, CNS and neuromuscular disorders, Alzheimer’s disease, and idiopathic pulmonary fibrosis and stroke. 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.

Quick View Natalizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Natalizumab
Administration Pathway
  • Intramuscular
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Gastrointestinal
  • Immunology
  • Oncology
Key Developers
  • Sponsor Company: Biogen
  • Originator: Elan
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.