23. Inrebic

Bristol-Myers Squibb
(Bristol-Myers Squibb)

Active ingredient: fedratinib
Disease: myelofibrosis
Peak sales estimate: $400 million
Approved: Aug. 16, 2019
Company: Bristol-Myers Squibb (Celgene)

The scoop: When Bristol-Myers Squibb made its whopping $74 billion deal for Celgene, the latter’s “Big 5” late-stage candidates were touted as a centerpiece of the agreement. In a boon for Bristol-Myers, the first of those––myelofibrosis drug Inrebic (fedratinib)––notched an FDA approval in August. Inrebic won approval as a first-line or follow-up treatment for myelofibrosis. The once-daily oral drug is the first new treatment in nearly a decade approved to treat the disease, Celgene said. It’s not all great news for Inrebic, though: The drug will come with a black-box warning for serious and fatal encephalopathy, including Wernicke’s. The drugmaker said serious encephalopathy was reported in 1.3% of trial patients treated with Inrebic, and one of those patients died. The story of Inrebic’s success is a major win for Celgene, which picked up the drug as part of a $1.1 billion acquisition of Impact Biomedicines in early 2018. Before that, Inrebic had passed through multiple hands after it was developed by TargeGen and then acquired by Sanofi. The French drugmaker ultimately called off its clinical trials in 2013 after the FDA placed a hold on the drug. –– Kyle Blankenship

23. Inrebic

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