Hanmi Pharmaceutical said its self-developed arthritis treatment Hyalrheuma Inj. obtained sales approval from the U.S. Food and Drug Administration, the first as a hyaluronic acid product among Korean drugs.
Hyalrheuma is a polymer hyaluronic acid injection developed with Hanmi’s advanced fermentation technology. It is directly administered to joints.
With the FDA’s nod, Hanmi and its partner company Teva plan to sell the treatment across the U.S. in earnest, according to Hanmi.
To get the U.S. approval, Teva conducted phase-3 clinical trials in 600 patients in the U.S. Hanmi received an FDA inspection on the Hyalrheuma-producing plant.
In 2014, Hanmi signed a deal with Actavis, the top drugmaker in generic medicines in the U.S., to export Hyalrheuma to the U.S. As Teva acquired Actavis in August 2016, Hanmi’s partner firm for Hyalrheuma was changed to Teva.
“We’re glad that Hyalrheuma passed the strict FDA inspection and won approval in the world’s largest pharmaceutical market, as the first Korean hyaluronic acid product,” an official at Hanmi Pharm said. “We will commit to raising the quality of life not only in Korea but the world through Hanmi’s technological power and brand.”