FDA approved Idhifa
Thanks to the FDA’s accelerated approval Tuesday of Idhifa from partners Celgene and Axios, patients with a specific type of acute myeloid leukemia receive the first registered medication for this type of treatment.
Idhifa received agency support for the treatment of patients with recurrent/refractory acute myeloid leukemia and IDH2 mutation, becoming the first drug that represents between 8% and 19% of all AML patients, according to the Celgene report.
“With this approval, Agios enters the ranks of commercial-stage biotechs,” Suneja wrote, adding that Celgene’s “extensive collaboration strategy is successfully helping the company in further diversifying its business.” The analyst noted Idhifa is available today.
Celgene entered its cancer-metabolism partnership with Agios back in 2010, picking up global development and commercialization rights to the candidate. The partners will co-market the drug in the U.S., and “Celgene will reimburse Agios for costs incurred for its co-commercialization efforts,” according to a release.
Approval on Tuesday was already 27th this year. Last year, the agency approved only 22 new drugs.