Fedratinib is under clinical development by Bristol-Myers Squibb and currently in Phase II for Myelodysplastic Syndrome. According to GlobalData, Phase II drugs for Myelodysplastic Syndrome have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Fedratinib’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.

Fedratinib overview

Fedratinib (Inrebic, Fedratinib dihydrochloride) is an antineoplastic agent. It is formulated as hard gelatin capsules, hard capsules for oral route of administration. Fedratinib is indicated for the treatment of adult patients with intermediate-2  or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Treatment of splenomegaly or disease associated symptoms in patients who have failed ruxolitinib or who could not tolerate it with primary myelofibrosis, or with secondary myelofibrosis as a complication of polycythemia vera or essential thrombocythemia.

Fedratinib (SAR-302503) is under development for myelofibrosis, primary and secondary myelofibrosis, atypical chronic myeloid leukemia, myelodysplastic syndrome and chronic neutrophilic leukemia. It was also under development for high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis in Japan.

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.

For a complete picture of Fedratinib’s drug-specific PTSR and LoA scores, buy the report here.

GlobalData

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.