FDA Approves Johnson & Johnson’s Schizophrenia Injectable

September 09, 2021 - FDA recently approved Johnson & Johnson’s long-acting atypical antipsychotic, Invega Hafyera, the first and only twice yearly injectable to treat schizophrenia in adults. 

Providers must administer Invega Sustenna to patients for at least four months, or Invega Trinza for at least one 3-month injection cycle, before transitioning to Invega Hafyera. 

Invega Hafyera dissolves slowly into the bloodstream after injection, allowing healthcare professionals to monitor and control treatment and symptoms over six months. 

“Long-acting injectable treatments offer a number of advantages compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods,” Bill Martin, PhD, global therapeutic area head of neuroscience at Janssen Research & Development, said in the announcement.

FDA based its approval of Invega Hafyera on a 12-month, randomized Phase 3 global trial, which enrolled 702 adults with schizophrenia from 20 countries. 

In the trial, researchers found that 92.5 percent of patients treated with Invega Hafyera and 95 percent of patients treated with Invega Trinza were relapse-free at 12 months. The safety profile for Invega Hafyera was also consistent with previous studies, and no new safety signals emerged. 

Johnson & Johnson’s long-acting injectable treatment portfolio for schizophrenia includes Risperdal Consta, Invega Sustenna, Invega Trinza, and Invega Hafyera. 

“The approval of Invega Hafyera builds on our 60-year legacy of delivering transformational medicines for adults living with schizophrenia,” said Mathai Mammen, MD, PhD, global head of  Janssen research & development at Johnson & Johnson. 

“This approval further underscores our steadfast commitment to addressing critical unmet needs, including treatment adherence concerns, faced by adults living with schizophrenia,” Mammen concluded. 

FDA Approves Merck’s Keytruda for Bladder Cancer

FDA recently approved Merck’s Keytruda for first-line advanced urothelial carcinoma. 

As part of the label update, FDA revised the indication to treat patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. 

FDA approved the drug under accelerated approval based on tumor response rate and duration of response. Previously, FDA’s Oncological Drugs Advisory Committee members voted (5-3) in favor of maintaining the accelerated approval of Keytruda for its first-line bladder indication.

In July, FDA approved the combination of Keytruda and Eisai’s tyrosine kinase inhibitor, Lenvima, to treat patients with advanced endometrial carcinoma.

The combination treatment is intended for patients who experienced disease progression following systemic therapy, who have endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and are not candidates for curative surgery.

FDA Approves Treatment for Waldenström’s Macroglobulinemia

FDA recently approved BeiGene’s Brukinsa to treat adult patients with Waldenström’s macroglobulinemia.

FDA based its approval on efficacy results from the multi-center, open-label Phase 3 ASPEN trial, which compared Brukinsa to ibrutinib in patients with Waldenström’s macroglobulinemia. Researchers enrolled 201 patients with MYD88 mutation in the randomized Cohort 1.

The trial’s primary endpoint was a very good partial response rate (VGPR) in the overall population. Brukinsa elicited a 28 percent VGPR, while ibrutinib elicited a 19 percent VGPR.  

Additionally, the response rate in patients who received Brukinsa was 78 percent, compared to 78 percent in patients treated with ibrutinib. And the event-free duration of response at 12 months was 94 percent with Brukinda, compared to 88 percent with ibrutinib. 

“We are delighted by today’s FDA approval for Brukinsa in its second indication, offering a new treatment option with demonstrated efficacy and safety benefits for patients with Waldenström’s macroglobulinemia,” Jane Huang, MD, chief medical officer of hematology at BeiGene, said in the announcement. 

“With 11 regulatory approvals in under two years, Brukinsa is demonstrating its growing utility as a treatment option for B-cell malignancies and expanding its footprint to potentially benefit more patients worldwide,” Huang continued. 

BeiGene will continue to evaluate Brukinsa in broad global clinical programs.