FDA OKs Injectable Antibiotic for Three Different Uses
The FDA approved the injectable drug ceftobiprole medocaril sodium (Zevtera) to treat adults with Staphylococcus aureus bacteremia (SAB), the agency announced Wednesday. The antibiotic prodrug is indicated for people with right-sided infective endocarditis, those with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients 3 months to less than 18 years […]
Long-Acting Injectable Comparable to Oral ART for HIV in Sub-Saharan Africa
DENVER — Long-acting cabotegravir/rilpivirine (Cabenuva) injectable therapy resulted in similarly high levels of viral suppression to oral antiretroviral therapy (ART) in African patients with HIV, a phase IIIb randomized, open-label trial showed. At 48 weeks, 96.9% of participants receiving cabotegravir/rilpivirine had a viral load of less than 50 copies/mL compared with 97.3% of those receiving […]
Tirzepatide Wins FDA Approval for Weight Loss
The FDA approved tirzepatide (Zepbound), the latest injectable for chronic weight management in adults, the agency announced on Wednesday. The combination glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist is indicated for adults with obesity or overweight with at least one weight-related condition, alongside a reduced-calorie diet and increased physical activity. Eli Lilly’s […]
Physicians Struggle to Help Diabetes Patients Get Tirzepatide
Endocrinologists say patients are once again having trouble accessing injectable medications they use to control type 2 diabetes, this time with tirzepatide (Mounjaro). Thanks to record demand, supply chain issues, and what some experts say is inappropriate off-label prescribing, endocrinologists said there has been a shortage in recent weeks which has pharmacies backed up and […]
FDA Moves to Pull Controversial Preterm Birth Drug From the Market
The FDA is calling for withdrawal of the approval for the injectable agent 17α-hydroxyprogesterone caproate (17-OHPC; Makena) for pregnant women with a history of at least one spontaneous preterm birth, stating that the drug is ineffective in reducing preterm births, as well as other poor neonatal outcomes, according to briefing documents released ahead of a […]
FDA Approves First Long-Acting Injectable to Prevent HIV Infection
The first long-acting injectable for HIV prevention has now been approved for use, the FDA announced on Monday. Long-acting injectable cabotegravir (CAB-LA, branded as Apretude) is administered as a monthly injection for the first 2 months, then every 2 months afterwards. It is the first long-acting injectable for pre-exposure prophylaxis (PrEP). The drug is approved […]
Long-Acting Injectable for HIV Prevention Passes Hurdles, but Barriers Remain
Long-acting injectable HIV prevention with cabotegravir was superior to daily oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine (TDF/FTC; Truvada) in men who have sex with men (MSM) and transgender women, a randomized trial found. Among more than 4,500 participants in the phase IIb/III trial, 13 incident infections occurred in the cabotegravir group compared with […]
Survey Probes Barriers to Long-Acting Injectable PrEP for MSM
Fear of potential severe side effects may be the greatest barrier to long-acting injectable HIV prevention among men who have sex with men (MSM), followed by out-of-pocket costs, a researcher said. When examining relative importance of perceived barriers to long-acting injectable pre-exposure prophylaxis (PrEP), perceived side effects was the most important, representing 52% of the […]