Four years ago in 2013, Sanofi was running different clinical trials to establish fedratinib as the backbone of its oncology portfolio. In the course of a week, the FDA ordered a clinical halt and Sanofi threw away the JAK2 inhibitor. Currently, members of the team who developed Fedratinib have revived it from the dead.
Fedratinib’s second act formally started today with a $22.5 million investment by Medicxi in Impact Biosciences, the biotech created to rescue the cancer candidate from clinical limbo. The impact will use the cash to perform the development and manufacturing tasks that stand between fedratinib and its widespread use in myelofibrosis (MF) and polycythemia vera.
Analytically, Impact has also convinced the FDA to lift the clinical hold. The FDA came to a decision after holding a Type A meeting and reviewing other data. Afterwards, the agency went lengths to validating Impact’s belief the benefits of fedratinib overshadow the risks.
“There are very limited therapeutic options for these patients and fedratinib was active in most patients when nothing else had worked,” Impact CEO John Hood, Ph.D., stated. “Because of the very high unmet medical need in MF, the Impact team completed a thorough review of the available data, including careful due diligence into the potential cases of WE and I am glad to report that as a result of this effort, the FDA has lifted the clinical hold.”
The FDA affected the drug with a clinical pause after finding out cases of the acute neurological condition Wernicke encephalopathy. Sanofi hid the programs days later. The pharma company made the choice after discussions with the FDA, study investigators, neurologists, and neuroradiologists spearheaded it to result in the risks outweighs the benefits.
Sanofi reported four cases of WE in the 877 subjects who participated in 18 studies of fedratinib before it was put on ice. All the cases happened in patients who were administered 500-mg doses.