US FDA approves Triastek application for Med™ 3D printed pharmaceutical product

KUALA LUMPUR, Feb 10 -- The United States Food and Drug Administration (FDA) recently approved Triastek Inc (Triastek) Investigational New Drug (IND) 505(b)(2) application for its first 3D printed drug product – T19.

According to a statement from the pharmaceutical company specialising in 3D printing of drug products, it is indicated for the treatment of rheumatoid arthritis (RA).

Developed in-house, Triastek has global intellectual property rights to the T19 3D printed formulation.

The novel design made possible by 3D printing allows T19 to function as a chronotherapeutic drug delivery system, targeting the circadian nature of RA symptoms.

T19 utilises Melt Extrusion Deposition (MED™) 3D printing technology to achieve three-dimensional tablet structures, allowing precise control of drug release to achieve the desired target PK in the human body.

Following T19, Triastek has developed 505(b)(2) product portfolio to meet specific clinical needs and improve outcomes of drug therapy using MED™ 3D printing technology.

Triastek plans to apply for IND approval in China later this year, followed by applications in Japan and Europe. The New Drug Application of T19 is expected to be filed to the US FDA in 2023.

-- BERNAMA