Teva Pharmaceuticals, MedinCell get UZEDY FDA approval for schizophrenia

Teva Pharmaceuticals and MedinCell have bagged approval for UZEDY (risperidone) extended-release injectable suspension from the US Food and Drug Administration (FDA) for schizophrenia treatment in adults.

UZEDY is a subcutaneous, long-acting formulation of risperidone that uses MedinCell’s copolymer technology SteadyTeq that regulates the fixed release of risperidone. Therapeutic blood concentrations are achieved within six to 24 hours of a single dose, said Teva Pharmaceuticals and MedinCell.

Richard Francis — Teva Pharmaceuticals President and CEO said: “UZEDY embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse.”

UZEDY FDA approval was driven by the findings of a couple of phase 3 clinical trials – TV46000-CNS-30072 and TV46000-CNS-30078.

In one of the phase 3 clinical trials, UZEDY showed a reduction of up to 80% in the risk of schizophrenia relapse compared to placebo.

Christophe Douat — MedinCell CEO, commenting on UZEDY FDA approval, said: “The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit.

“We are committed to supporting patients through innovative therapy options. It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of UZEDY. Our technology reaching commercial stage marks the start of an exciting new era for MedinCell and we are extremely proud to share this very special moment with all our employees and shareholders.”

UZEDY is a subcutaneous injection from a pre-filled syringe with a needle of 21 gauges.