FDA To Discuss Approval For Amylyx’s Experimental ALS Drug Again Today
Read about the biggest pharmaceutical developments and pricing stories from the past week in KHN's Prescription Drug Watch roundup.
The Washington Post:
Showdown Over Experimental ALS Drug Expected Wednesday Before FDA Advisers
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 —
CIDRAP:
Full-Dose Anticoagulation Drugs Best For Preventing COVID-19 Blood Clots
Full-dose anticoagulation medication was better at preventing COVID-19–related blood clots in hospitalized patients than standard prophylactic dosing, according to a new study in Circulation. (8/30)
CIDRAP:
Hospitals Still Used 2 COVID Monoclonals After FDA Deauthorization
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 —
CIDRAP:
Study Finds Antibiotic Use High In Kids' ICUs, With A Third Deemed Improper
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)
The Atlantic:
Lowering The Cost Of Insulin Could Be Deadly
This is where addressing the cost of insulin—and only insulin—becomes 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’m a senior resident, told me that plenty of her patients can’t afford SGLT2 inhibitors and GLP-1 receptor agonists. In such instances, Shaw is forced to use older oral alternatives and occasionally insulin. “They’re better than nothing at all,” she said. (Rose, 9/5)
Bloomberg:
Drug Recalls For Nitrosamines Could Cost Big Pharma Millions
When a drug is recalled because there’s something in it that shouldn’t be, it’s 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—and difficult to eradicate—form of contamination has surfaced among makers of some of the world’s best-selling pharmaceuticals. They’re called nitrosamines. (Edney, 9/1)
New England Journal of Medicine:
Bedaquiline–Pretomanid–Linezolid Regimens For Drug-Resistant Tuberculosis
The bedaquiline–pretomanid–linezolid 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)
