Entering J&J's fiefdom, Luye wins FDA approval of long-acting schizophrenia drug

Luye Pharma has entered a space targeted by Johnson & Johnson and Teva, securing FDA approval for its extended-release injectable formulation of risperidone in schizophrenia and bipolar I disorder.

J&J has used long-acting injectable drug delivery technology to create a schizophrenia franchise worth billions of dollars. The success of the products has attracted competitors. Teva was initially knocked back by the FDA but is now closing in on a potential approval of its risperidone formulation. Back in 2021, then-CEO of Teva Kåre Schultz said the goal was to capture 10% of the blockbuster market.  

Teva’s stumble has enabled Luye, a China-based drugmaker, to beat it to market. The FDA approval covers a formulation of decades-old medicine risperidone that uses microsphere technology to extend the gap between intramuscular injections to two weeks. The drug, branded Rykindo, is indicated in the treatment of schizophrenia and as monotherapy or adjunctive therapy for the maintenance treatment of bipolar I disorder. Use of Rykindo is limited to adults in each setting.

Luye secured the approval after running a series of clinical trials, including two studies that compared its formulation to J&J’s Risperdal Consta. J&J first won FDA approval for the long-acting risperidone product Risperdal Consta almost 20 years ago and has since rolled out other medicines that use different active ingredients and are given as infrequently as twice a year.

Luye’s microspheres are unable to match J&J’s low water solubility approach or the depot technology used by MedinCell, the company behind Teva’s candidate, in terms of dose frequency. But there remains a commercial opportunity for schizophrenia drugs that, like Rykindo, are given every two weeks. 

J&J’s Risperdal Consta, a risperidone formulation that is given every two weeks, racked up global sales of $373 million over the first nine months of last year. J&J generated more than half the sales in the U.S. Sales are down compared to the first nine months of 2021.