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US FDA greenlights TTY Biopharm’s leukemia drug

Source: Taipei Times

The US Food and Drug Administration (FDA) has approved a generic drug developed by Taiwan-based TTY Biopharm Co Ltd (台灣東洋藥品) to treat acute promyelocytic leukemia (APL), the company said on Sunday.

The drug, arsenic trioxide, sold under the brand name Asadin, was first approved for medical use in the US last year, and is listed by the WHO as an essential medicine for treating APL.

APL, a rare form of acute myeloid leukemia (AML), is distinguished by there being too many immature blood-forming cells in the blood and bone marrow, which leads to a shortage of normal white and red blood cells in the body.

It needs to be treated differently from other types of AML, and arsenic trioxide combined with all-trans retinoic acid has become the standard 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 diagnosis and medication.

TTY Biopharm said in a statement that it hoped the approval of its generic drug could help patients in the US.

The company first received a license to make the drug from the Taiwanese FDA in 2002. It was the first APL treatment license issued in Taiwan.

From 2018, the company developed the drug further under a milestone payment contract with another partner, which it did not identify.

The partner is responsible for the sale, licensing and approval of the TTY Biopharm’s generic drug in international markets, such as Malaysia, the Philippines, Thailand, the US and Vietnam.

The US FDA approval was the first received by TTY Biopharm for any of its drugs, and recognizes the company’s research and development capabilities and manufacturing strength, the company said.

As 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.

In related news, TTY Biopharm’s board of directors yesterday approved the dismissal of general manager Shih Chun-liang (施俊良), after Shih admitted to being involved in an insider-trading scandal involving the company’s shares.

TTY Biopharm chairman Lin Chuan (林全) is also to act as general manager, the company said in a regulatory filing.

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