Agios Pharmaceuticals Drug for Leukemia Receives U.S. Approval

On Friday, Agios Pharmaceuticals announced that the United State Food and Drug Administration had granted approval for its treatment for a specific form of leukemia, the first treatment that is targeted for patients that have a specific genetic mutation.

The company is planning to launch its newly approved drug, known as Tibsovo, across the U.S. in the next two days, said David Schenkein the CEO.

Agios is planning to sell the leukemia treatment at $26,115 to drug distributors for a supply of 30 days, said Schenkein.

Tibsovo is the first fully-owned drug for Agios and was approved thanks to the results from patients in an early-stage trial that suffered from acute myeloid leukemia and their disease was either resistant to treatments or had relapsed.

The label on the drug contains a boxed warning, which is the agency’s harshest, as it flags the danger of possible differentiation syndrome, which is a fatal condition if left untreated, with symptoms that include the buildup of fluid in the lungs as well as inflammation of the lung’s tissue.

Across the U.S., close to 20,000 new cases of acute myeloid leukemia are diagnosed annually. The sickness is a cancer of the bone marrow and blood, said the company in an official statement following the approval of its drug.

The Agios CEO said the approval of the drug was a huge milestone for the estimated 5% to 10% of acute myeloid leukemia patients that have the IDH1 mutations, which is the specific form of the disease that will be targeted by Tibsovo.

In August, another cancer treating drug was approved by the FDA from Agios, but the worldwide developing and commercializing rights belong to the company Celgene.

Over the last year, shares of Agios have gained almost 62%, but were marginally lower on Friday.