Celgene's Big Win

Celgene's Big Win | FDA Approved AML Drug

FDA approved Leukemia treatment developed by Celgene and Agios on 1st August 2017. The drug will now be sold as Idhifa. Idhifa is the first and only FDA-approved therapy for patients with an IDH2 mutation, a group that accounts for 8 to 19 percent of all AML patients. In the United States, that translates to about 1,200 to 1,500 patients, Celgene said.

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.

Oppenheimer's Leah Rush Cann said in a client note that the drug could generate sales of $1.4 billion in 2021.

The relationship paid off nicely for Celgene. The journey from first-in-human testing to a regulatory filing took just three years, an incredibly fast speed in R&D. And Agios plans to do that again with other drugs in its pipeline. Leerink’s says it’s a big step for both companies, which will be followed closely during the market launch.

The relationship paid off nicely for Celgene. The journey from first-in-human testing to a regulatory filing took just three years, an incredibly fast speed in R&D. And Agios plans to do that again with other drugs in its pipeline. Leerink’s says it’s a big step for both companies, which will be followed closely during the market launch.