After 20 years developing technology for slow-release injectable drugs, MedinCell of France has won its first FDA approval.
In combination with Teva, MedinCell has scored an FDA nod for Uzedy (risperidone), an extended-release injectable suspension treatment for adults with schizophrenia.
The endorsement comes 12 months after the FDA sent a complete response letter to the companies, rejecting the treatment. Shortly after the companies refiled for approval in November, MedinCell received a 40 million euro ($42 million) loan from the European Investment Bank to continue developing its technology.
“The approval of the first product formulated with our technology is a pivotal moment for MedinCell,” the company’s CEO Christophe Douat said in a release. “Our technology reaching commercial stage marks the start of an exciting new era for MedinCell.”
Uzedy will be available in the U.S. in “the coming weeks” at a wholesale cost of $1,232 to $3,080 per month, depending on the dosage strength, the companies said.
The drug can be administered at one- or two-month intervals. After it is dosed, therapeutic blood concentrations are reached in six to 24 hours, MedinCell said.
Originally developed by Johnson & Johnson and known commercially as Risperdal, the antipsychotic drug was first approved by the FDA 30 years ago. Teva brought a generic version of risperidone to the market more than a dozen years ago.
MedinCell’s BEPO technology—also called SteadyTeq—is based on copolymers and a biocompatible solvent that are formulated along with the active ingredient. After dosing, the ingredient is trapped in a depot that gradually degrades, allowing the drug’s slow release.
Uzedy’s approval is backed by two phase 3 trials. In the RISE study of 544 patients, the one-month regimen of Uzedy reduced the risk of relapse compared with placebo by 80%. The risk reduction associated with the two-month regimen was 63%.
The SHINE study evaluated adverse events with 336 patients and produced similar results to the RISE trial.
Uzedy joins a crowded field of longer-acting schizophrenia drugs, including Otsuka and Lundbeck’s Abilify Asimtufii, which also was approved last week, with its injected dose lasting for two months.
J&J dominates the market with its long-acting schizophrenia drugs that sustain efficacy for three and six months. Last year, J&J’s Invega Sustenna and Invega Trinza franchise racked up sales of $4.1 billion.
The company also had sales of $488 million for Risperdal Consta, which is taken every two weeks as a maintenance therapy for biopolar disorder.
Approximately 80% of patients with schizophrenia experience multiple relapses over their first five years of treatment, most commonly because of suboptimal adherence to daily, oral antipsychotics, MedinCell said.