FDA Eases Access To Medication For Treatment-Resistant Schizophrenia
The agency is eliminating a long-held blood test requirement, broadening access to clozapine. Also, new clinical trial results show hope for those with sickle cell disease and could lower the cost of treatment. Other news is on compounding pharmacies lawsuit against the FDA, promising cancer drugs, and more.
The New York Times:
F.D.A. Expands Access To Clozapine, A Key Treatment For Schizophrenia
The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses. The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled. (Barry, 2/25)
Axios:
New Sickle Cell Treatment Cures Disease At Lower Cost Than Gene Therapies
A new type of bone marrow transplant can cure sickle cell disease with only half of the donor's cell proteins matching, according to new clinical trial results published in the New England Journal of Medicine. The procedure would greatly expand the pool of potential donors, in addition to costing less than one-quarter of the price of innovative gene therapies for the condition that have earned Food and Drug Administration approval in recent years. (Goldman, 2/26)
The Wall Street Journal:
AstraZeneca’s Breast Cancer Drug Shows Positive Results In Late-Stage Trial
AstraZeneca said its breast cancer drug candidate showed positive results in a late stage trial, with improved progression-free survival in patients. The British pharma giant said Wednesday that the trial for Camizestrant showed statistically significant and clinically meaningful improvement in progression-free survival compared with the standard-of-care treatment. For the trial the drug was combined with a cyclin-dependent kinase inhibitor, which slows cell proliferation. The experimental pill also showed improved trends of delayed progression to secondary disease. (Smolak, 2/26)
MedPage Today:
A Good Number Of Cancer Patients In Mid-Stage Trials Get Drugs Later Approved
One in six patients in phase II oncology clinical trials received a treatment that was eventually approved by the FDA, according to a longitudinal study. In a sample of 400 phase II trials that included 25,000 participants, a total of 4,045 patients (16.2%) received a treatment that advanced to FDA approval, reported Jonathan Kimmelman, PhD, of the McGill University School of Population and Global Health in Montreal, and colleagues in the Journal of the National Cancer Institute. (Bassett, 2/25)
The Hill:
Drug Compounders Sue Over Weight Loss Drugs’ Removal From FDA Shortage List
A trade group representing compounding pharmacies has filed a lawsuit against the Food and Drug Administration (FDA) for removing semaglutide, the active ingredient in Ozempic, from its drug shortage list. (Choi, 2/25)
MedPage Today:
Aspirin For Sepsis Flops In Trial
Aspirin failed to cut the intensity of organ dysfunction in patients with sepsis, a placebo-controlled phase II trial from Brazil showed. For the primary endpoint ... there was no significant difference between groups. ... Yet aspirin "increased the risk of severe bleeding compared to placebo," said Thiago Miranda Lopes de Almeida, PhD, of Hospital São Paulo in Brazil, in a presentation here at the Society of Critical Care Medicine annual meeting. (Susman, 2/25)
NPR:
Did An Alzheimer’s Drug Give Sue And Ken Bell More Time? Maybe
In 2020, Sue Bell became one of the first Alzheimer's patients in the U.S. to receive the drug now marketed as Leqembi. Four years later, she and her husband, Ken, halted the treatment. Sue's Alzheimer's had reached the point where her taking the drug no longer made sense. "I think it helped," says her husband, Ken Bell. "But I'm not sure." (Hamilton, 2/26)
