J&J (JNJ) Gets FDA Nod for Twice-Yearly Schizophrenia Drug

Johnson & Johnson JNJ announced that the FDA has approved another long-acting formulation of its antipsychotic drug, paliperidone palmitate, Invega Hafyera, for treating schizophrenia in adults.

Invega Hafyera is a long-acting injectable treatment, which will be administered every six months. The new long-acting formulation results in continuous treatment and symptom control over six months. The drug is the first and only FDA-approved twice-a-year treatment for schizophrenia. It offers schizophrenia patients the fewest doses per year for their treatment.

Please note that two other formulations of paliperidone palmitate — Invega Sustenna and Invega Trinza — are already approved to treat schizophrenia. While Invega Sustenna needs to be administered every month, Invega Trinza is administered once every three months. We note that a tablet formulation of paliperidone, Invega, was the first to receive FDA approval as acute and maintenance treatment of schizophrenia in 2006. It needs to be administered every day.

J&J has come a long way over the last 15 years in developing improved treatment options which significantly improves convenience for schizophrenia patients. The reduced administrations will help patients control their disorder with a better treatment plan.

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This year so far, J&J’s shares have risen 10.4% compared with an increase of 15.4% for the industry.

The approval of Invega Hafyera was based on data from a global phase III study that evaluated Invega Hafyera for non-inferiority compared to Invega Trinza. Data from the study demonstrated that 92.5% of patients who were administered Invega Hafyera were relapse-free at 12 months compared to 95% for Invega Trinza. The safety profile of Invega Hafyera was consistent with the safety profile of Invega Sustenna and Invega Trinza observed in previous studies.

Meanwhile, we note that J&J’s Invega franchise has maintained strong growth over the past few years. Worldwide sales from this franchise were almost $2 billion in the first half of 2021, gaining more than 10% year over year.

However, as Invega Sustenna and Invega Trinza get older, the risk of generics rises. Several generic-makers including Teva TEVA, Viatris VTRS, and Mallinckrodt Pharmaceuticals are trying to get approval for the generic version of either of these two drugs. J&J has initiated litigations against these companies to retain patent exclusivity. Moreover, the approval of Invega Hafyera provides long-term protection to J&J’s sales from the Invega franchise as it will have a longer patent exclusivity.

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Zacks Rank & Stock to Consider

J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked stock from the biotech sector is Regeneron REGN, which sports a Zacks Rank #1.

Regeneron’s earnings per share estimates have moved north from $49.96 to $54.15 for 2021 and from $40.91 to $44.11 for 2022 in the past 30 days. The stock has risen 41% so far this year.

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