The United States Food and Drug Administration (FDA) has approved a generic drug developed by Taiwan-based TTY Biopharm to treat acute promyelocytic leukemia (APL), the company said Sunday.
The drug, arsenic trioxide (brand name Asadin), was first approved for medical use in the U.S. in 2000, and is listed by the World Health Organization as an essential medicine for treating APL.
APL, a rare form of acute myeloid leukemia (AML), is characterized by too many immature blood-forming cells in the blood and bone marrow, leading to a shortage of normal white and red blood cells in the body.
It needs to be treated differently than other types of AML, and arsenic trioxide combined with all-trans retinoic acid has emerged as the standard course of treatment for the cancer.
When APL was first identified in 1957, APL patients had a median survival rate of less than a week, but now 10-year survival rates are plausible thanks to improvements in prognoses and medication.
In a statement Sunday, TTY Biopharm said it hoped the approval of its generic drug can help patients in the United States.
The company first received a license to make the drug from the Taiwan Food and Drug Administration in 2002, the first APL treatment license issued in Taiwan.
Since 2018, the company further developed the drug with another partner, which it did not identify, under a milestone payment contract.
The partner is responsible for the sale, licensing and approval of the TTY Biopharm’s generic drug in international markets, such as Vietnam, the Philippines, Malaysia, Thailand, and the U.S.
The U.S. FDA approval was the first received by TTY Biopharm for any of its drugs, and the milestone represented recognition of the company’s research and development capabilities and manufacturing strength, the company said in the statement.
Because the materials used to make the drug are highly toxic, the company has partnered with National Central University to create a recycling technique for arsenic ions that makes wastewater from the drug production process safe to release.
Source: Focus Taiwan News Channel