Biocon Ltd announced on Tuesday that its subsidiary has received additional authorization from the US health regulator for the drug Yesintek in a pre-filled auto-injector format.
The drug Yesintek is intended for the treatment of moderate and severe psoriasis, as well as active psoriatic arthritis. According to the company's statement in regulatory documentation, the American subsidiary received additional approval from the U.S. Food and Drug Administration (USFDA) for the Yesintek auto-injector with pre-filling in dosages of 45 mg/0.5 ml and 90 mg/ml.
The company specified that Yesintek was initially approved by the USFDA on November 29, 2024. The new delivery format as an auto-injector for single use provides patients with another significant treatment option. The company noted that this new method of administration supports more individualized approaches to treatment in various healthcare settings and depending on patient needs.
Yesintek is indicated for the therapy of moderate and severe psoriasis, as well as active psoriatic arthritis in adults and children over 6 years of age, and for the treatment of moderate and severe activity Crohn's disease and ulcerative colitis in adults. These conditions are among a range of debilitating autoimmune diseases affecting tens of thousands of Americans.
This additional approval expands Biocon's comprehensive portfolio of immunological products in the United States and confirms the company's commitment to improving global patient access to affordable medicines.