Morning Briefing
Summaries of health policy coverage from major news organizations
FDA To Discuss Approval For Amylyx's Experimental ALS Drug Again Today
On Wednesday, the FDA is holding a rare, second meeting with a panel of independent experts to discuss the treatment, and is expected to make a decision on approval by Sept. 29. ... ALS advocates hold out hope that the FDA will clear the treatment in the face of intense pressure from patients and their families. (McGinley, 9/6)
In covid treatment updates 鈥
Full-dose anticoagulation medication was better at preventing COVID-19鈥搑elated blood clots in hospitalized patients than standard prophylactic dosing, according to a new study in Circulation. (8/30)
US health systems administered more than 158,000 doses of two monoclonal antibodies (mAbs) to COVID-19 patients at a cost likely exceeding $71 million after the Food and Drug Administration (FDA) deauthorized their use because they didn't work against the Omicron variant. (8/30)
In other pharmaceutical news 鈥
A point-prevalence study in 10 medical centers across the United States reveals that almost 60% of pediatric intensive care unit (PICU) patients receive antibiotics, and researchers estimate that a third of antibiotic orders in PICUs are inappropriate, according to a study yesterday in Clinical Infectious Diseases. (9/2)
This is where addressing the cost of insulin鈥攁nd only insulin鈥攂ecomes problematic. Doctors are forced daily to decide between the best medication for our patients and the medication that our patients can afford. Katie Shaw, a primary-care physician with a bustling practice at Johns Hopkins, where I鈥檓 a senior resident, told me that plenty of her patients can鈥檛 afford SGLT2 inhibitors and GLP-1 receptor agonists. In such instances, Shaw is forced to use older oral alternatives and occasionally insulin. 鈥淭hey鈥檙e better than nothing at all,鈥 she said. (Rose, 9/5)
When a drug is recalled because there鈥檚 something in it that shouldn鈥檛 be, it鈥檚 scary but often traceable: Foreign objects such as shards of metal or microorganisms might infiltrate medications through dirty factories or lax manufacturing practices. But recently a more insidious鈥攁nd difficult to eradicate鈥攆orm of contamination has surfaced among makers of some of the world鈥檚 best-selling pharmaceuticals. They鈥檙e called nitrosamines. (Edney, 9/1)
The bedaquiline鈥損retomanid鈥搇inezolid regimen has been reported to have 90% efficacy against highly drug-resistant tuberculosis, but the incidence of adverse events with 1200 mg of linezolid daily has been high. The appropriate dose of linezolid and duration of treatment with this agent to minimize toxic effects while maintaining efficacy against highly drug-resistant tuberculosis are unclear. (Conradie, M.B., B.Ch., et al, 9/1)