Johnson & Johnson scores an FDA first with nod for twice-yearly schizophrenia drug Invega Hafyera

Johnson & Johnson thinks a longer-acting treatment against schizophrenia will help keep patients on their prescriptions and reduce their chances of a relapse. Now, with a FDA nod under its belt, the company is pushing Invega Hafyera as just the med to fit the bill. 

The FDA Wednesday approved J&J’s long-acting schizophrenia drug, previously known as paliperidone palmitate, for injection every six months. It's the first and only twice-yearly med for the condition. 

The new long-acting regime joins J&J’s existing one-month and three-month formulations, dubbed Invega Sustenna and Invega Trinza, respectively, plus a two-week injection known as Risperdal Consta.

Paliperidone, the active ingredient in the Invega products, is also sold in a daily tablet form as Invega. Oral antipsychotics are still the most commonly prescribed treatment against the condition, which is characterized by distortions in someone’s thinking, perception, emotions and behavior. 

But as J&J sees it, longer-acting injectables reduce the risk of patients forgetting to take a daily pill, which could lead to a schizophrenia episode and relapse. It’s thought that roughly half of patients who suffer from chronic schizophrenia stop taking their prescriptions after six months of treatment, J&J says. 

“We feel that the longer and longer that you extend out the dosing interval, the greater the compliance,” said Janssen’s Srihari Gopal, M.D., senior director, head of development, psychiatry. 

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The antipsychotic injectables have become the linchpin of the New Brunswick, New Jersey-based pharma’s neuroscience portfolio, raking in $3.6 billion last year. That represented a 9.7% increase compared with the prior year, according to J&J’s annual report

Even before the latest approval, the company was already on track to beat those figures in 2021. J&J has generated nearly $2 billion from the injectables in the first nine months this year, up 13% compared with the same period last year. J&J did not disclose the price for Hayfera but said it would vary by patient given that the dosing can range depending on a patient’s symptoms. 

The FDA based its approval on the results from J&J’s 702-patient Route 6 trial. In that study, investigators found that the six-month formulation’s performance held up with those already using the three-month injection to avoid relapse. 

RELATED: J&J seeks European approval for twice-yearly schizophrenia drug

Now that the six-month formulation has the FDA’s blessing, patients will be stabilized using a shorter-acting version before switching over, J&J says. That would mean at least four months spent on the monthlong formulation or just one cycle on the three-month formulation, Gopal said. 

“We knew going into this that doctors would be kind of reluctant to give a really big dose of something, especially something that lasted six months, to a patient without knowing that it’ll work or they’ll tolerate it,” Gopal said. 

While J&J dominates the long-acting injectable schizophrenia market, the company isn't alone. Japanese pharma Otsuka and partner Lundbeck also have a once-monthly injection to treat schizophrenia and bipolar disorder known as Abilify Maintena.