Fidanacogene elaparvovec is under clinical development by Pfizer and currently in Phase III for Hemophilia B (Factor IX Deficiency). According to GlobalData, Phase III drugs for Hemophilia B (Factor IX Deficiency) have a 79% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Fidanacogene elaparvovec’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.
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 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.
For a complete picture of Fidanacogene elaparvovec’s drug-specific PTSR and LoA scores, buy the report here.