Fidanacogene elaparvovec is under clinical development by Pfizer and currently in the Phase III 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 Fidanacogene elaparvovec’s likelihood of approval (LoA) and phase transition for Hemophilia B (Factor IX Deficiency) took place on 28 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Fidanacogene elaparvovec overview

Fidanacogene elaparvovec (SPK-9001, PF-06838435) is under development for the treatment of hemophilia B. The therapeutic candidate is administered by intravenous route as a solution. The therapeutic candidate uses an engineered adeno-associated virus to deliver the human FIX gene (AAV8-hFIX19 vector) to liver cells, where FIX is normally made. It is a new molecular entity.

Pfizer overview

Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.

Quick View Fidanacogene elaparvovec LOA Data

Report Segments
  • Innovator
Drug Name
  • Fidanacogene elaparvovec
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Hematological Disorders
Key Developers
  • Sponsor Company: Pfizer
  • Originator: Children’s Hospital of Philadelphia
Highest Development Stage
  • Phase III

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.