Drugs

FDA Approves 6-Month Schizophrenia Drug

FDA has approved Janssen’s Invega Hafyera (paliperidone palmitate) extended-release injectable suspension to treat schizophrenia in some adults. An agency statement says the atypical antipsychotic is the first long-acting schizophrenia medication to be injected once every six months.

Other long-acting injectable antipsychotics are administered every few weeks to every three months, FDA says.

Hafyera’s efficacy was evaluated in a study of 702 adults with schizophrenia who had previously been treated with either Invega Sustenna, a one-month extended-release injectable suspension, for at least four months, or Invega Trinza, a one-time three-month extended-release injectable suspension.

FDA says the trial was designed to evaluate whether the time to relapse for Hafyera administered every six months provided similar effectiveness as Trinza administered every three months. Among the treatment groups, 7.5% of patients in the Hafyera group experienced a relapse, compared to 4.9% of patients in the Trinza group.

Hafyera should only be used after a patient has been adequately treated with a one-month injectable suspension, such as Sustenna, for at least four months, or a one-time three-month injectable suspension such as Trinza, the statement says.

The most common side effects of Hafyera were upper respiratory tract infection, injection site reaction, weight gain, headache, and movement abnormalities. The drug includes a Boxed Warning that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The labeling contains additional Warnings and Precautions including possible cerebrovascular adverse reactions and neuroleptic malignant syndrome.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome