U.S. markets closed
  • S&P 500

    4,544.90
    -4.88 (-0.11%)
     
  • Dow 30

    35,677.02
    +73.94 (+0.21%)
     
  • Nasdaq

    15,090.20
    -125.50 (-0.82%)
     
  • Russell 2000

    2,291.27
    -4.92 (-0.21%)
     
  • Crude Oil

    83.98
    +1.48 (+1.79%)
     
  • Gold

    1,793.10
    +11.20 (+0.63%)
     
  • Silver

    24.39
    +0.22 (+0.91%)
     
  • EUR/USD

    1.1646
    +0.0015 (+0.13%)
     
  • 10-Yr Bond

    1.6550
    -0.0210 (-1.25%)
     
  • GBP/USD

    1.3760
    -0.0036 (-0.26%)
     
  • USD/JPY

    113.4800
    -0.5080 (-0.45%)
     
  • BTC-USD

    61,294.38
    +452.09 (+0.74%)
     
  • CMC Crypto 200

    1,453.34
    -49.69 (-3.31%)
     
  • FTSE 100

    7,204.55
    +14.25 (+0.20%)
     
  • Nikkei 225

    28,804.85
    +96.27 (+0.34%)
     

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

  • Oops!
    Something went wrong.
    Please try again later.
·3 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.

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.

Zacks Investment Research
Zacks Investment Research


Image Source: Zacks Investment Research

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.

Johnson & Johnson Price

Johnson & Johnson Price
Johnson & Johnson Price

Johnson & Johnson price | Johnson & Johnson Quote

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.


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report

Johnson & Johnson (JNJ) : Free Stock Analysis Report

Teva Pharmaceutical Industries Ltd. (TEVA) : Free Stock Analysis Report

Viatris Inc. (VTRS) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research