Top 8 FDA Approvals of 2018


The Contagion® editorial staff and members of the editorial board recap the top 8 FDA approvals of 2018.

The Contagion® editorial staff and members of the editorial board recap the top 8 FDA approvals of 2018:

#8: Expanded Use of Gardasil 9 — In October, the FDA granted expanded use of the 9-valent, recombinant human papillomavirus vaccine to include women and men from ages 27 to 45. Previously, the vaccine was only approved up to age 26. (Allie Ward, MA, Managing Editor of Contagion®)

#7: T2 Biosystems’ T2Bacteria Panel for rapid sepsis testing — I am most excited about the T2 Biosystems T2 Bacteria panel that was approved in May 2018. This is the first rapid diagnostic test that’s approved for testing directly from a blood sample. Within 5 hours of drawing that blood culture, you can have results back for 5 of the most common causes of sepsis, including: Staphylococcus aureus, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, andPseudomonas aeruginosa. This is amazing. This is going to be a game-changer. The only thing we are missing… is real-world clinical data. (Monica Mahoney, PharmD, BCPS-AQ ID)

#6: TPOXX (tecovirimat) for treatment of smallpox — My pick for the new FDA approval of 2018 is tecovirimat, or TPOXX. This drug was developed in conjunction with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and was approved in July 2018 as the first drug to treat smallpox. This approval is exciting because it gives us hope in a really scary situation in which no one is really vaccinated for smallpox anymore. This is really helpful in the event of an outbreak as TPOXX gives us treatment options. Whether that’s a laboratory incident or a bioterrorist attack, or a fluke of nature, TPOXX gives us a medical countermeasure, which is why it makes the top list for me. (Saskia v. Popescu, MPH, MA, CIC)

#5: Tafenoquine (ARAKODA) for the prevention of malariaApproved in August 2018, this is the first new drug approved for the prevention of malaria in more than 18 years. It protects against Plasmodium vivax and Plasmodium falciparum, killing the parasites in both the blood and liver. We need more investment in medicine for tropical infectious disease and the global health community welcomes any new developments in malaria prophylaxis. (Payal Patel, MD, MPH)

#4: Eravacycline (aka XERAVA)— The FDA approved this tetracycline-class antibacterial injection in August 2018 for the treatment of complicated intra-abdominal infections in adults 18 years and older. (Danielle Mroz, MA, Contagion® Associate Editorial Director)

#3: Omadacycline (aka NUZYRA) — This once-daily IV and oral antibiotic has activity against gram-positive, gram-negative, and drug-resistant strains of bacteria. It was approved in October for the treatment of community-acquired bacterial pneumonia and acute skin and skin structure infections in adults. (Allie Ward, MA, Managing Editor of Contagion®)

#2: Biktarvy for HIV-1 — I chose Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) for HIV-1. This single-tablet regimen approved in February 2018 combines a TAF backbone with a new integrase inhibitor, bictegravir. This is the go-to drug in 2018 for new HIV diagnoses. Doctors love it, patients love it, there are few, if any drug interactions, and it’s incredibly well-tolerated, and it’s very very small in size, which is wonderful. So, for 2018, I pick, BIC. (Sarah Schultz, MD)

#1: Plazomicin for treatment of cUTIs in adults — Plazomicin, brand name Zemdri. This once daily intravenous aminoglycoside was approved in June 2018 for adults with complicated urinary tract infections (cUTIs) including acute pyelonephritis, for patients with limited or no other treatment options. It has in vitro activity against carbapenem-resistant Enterobacteriaceae and extended-spectrum beta-lactamase-producing gram-negative rods. Why is this significant? Don’t we have enough UTI drugs already? Well, in addition to the cUTI study that led to its approval, a prospective study of patients with CRE infections compared plazomicin to colistin-based therapy and showed plazomicin to be superior, and I love therapies that are better than colistin. (Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS)

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