Celgene and Agios win FDA approval for targeted AML drug Idhifa

Idhifa from Celgene and Agios won FDA approval Tuesday.

Patients with a specific type of acute myeloid leukemia have their first treatment option with the FDA’s approval Tuesday of Idhifa from partners Celgene and Agios.

Idhifa won the agency’s backing to treat relapsed/refractory AML patients with an IDH2 mutation, becoming the first such drug for a group that represents between 8% and 19% of all AML patients, according to a release from Celgene. It’s also the first oral, targeted inhibitor for the mutation to win agency backing.

The companies priced the drug, which was granted orphan status, at $24,872 per month before discounts, according to a Tuesday note from SunTrust analyst Yatin Suneja, significantly higher than a $14,000 figure he had modeled. According to Suneja, Celgene expects peak sales of $500 million in the setting.

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“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.

The approval comes ahead of the FDA’s decision date for the drug of August 30. Idhifa won a priority review back in March, and was approved Tuesday for use with a companion diagnostic from Abbott.

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For Agios, Suneja figures the approval bodes well for its wholly owned IDH1 inhibitor AG-120. Data on that candidate in relapsed/refractory AML are expected by the end of the year. A spokesperson for Agios said the company plans to add 50 to 100 jobs by the end of the year. As of now, the biotech employs about 350 people.

Tuesday’s nod pushed the FDA’s new drug approval tally to 27 for the year after green lights for Gilead’s Vosevi, Puma’s Nerlynx and Janssen’s Tremfya last month. The agency approved just 22 new drugs last year.