The US Food and Drug Administration (FDA) approved multiple previously-approved medication for additional indications in November 2020, including Xofluza for postexposure prevention of influenza. As the US experiences a surge in cases of coronavirus disease 2019 (COVID-19), these FDA approvals are of import to nurse practitioners (NPs) and physician assistants (PAs) who are treating patients with life-threatening diseases that put them at an increased risk for severe COVID-19. The FDA also approved a first-of-its-kind treatment for Hutchinson-Gilford Progeria Syndrome (HGPS), which has been proven to reduce mortality for patients with the rare, aggressive disease.
Xofluza for Postexposure Prevention of Influenza
Xofluza® (baloxavir marboxil; Genentech) was FDA approved in 2018 to treat influenza in patients aged 12 years and older. In November 2020, the FDA approved Xofluza as a prophylactic measure for patients aged 12 years and older who were exposed to a contact with influenza. The approval follows a randomized, double-blind clinical trial in which 1% of participants with household contacts infected with the influenza virus developed influenza, vs 13% of participants in the placebo group.1
For patients weighing less than 80 kg, the recommended dose of Xofluza is 40 mg; for patients who weigh 80 kg or more, the recommended dose is 80 mg.1 Xofluza is available in both tablet and oral suspension form.
Keytruda for Triple-Negative Breast Cancer
Keytruda® (pembrolizumab; Merck) was approved for intravenous use in 2014, but the 2020 approval expands therapeutic options for patients with triple negative breast cancer (TNBC). For patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (Combined Positive Score ≥ 10), Keytruda can be used in combination with chemotherapy.2
In a double-blind, placebo-controlled clinical trial, participants who were given Keytruda had a median progression-free survival rate of 9.7 months vs 5.6 months for the placebo group.2
Brilinta for High-Risk Stroke
Brilinta® (ticagrelor; AstraZeneca) is now approved for use in combination with aspirin to manage patients who have a high risk of acute ischemic stroke or transient ischemic attack.
In a randomized, double-blind clinical trial, participants who were treated with Brilinta had a 17% relative reduced risk and 1.1% absolute reduced risk for a fatal stroke.3 The medicine is available in 60 mg and 90 mg tablets.
Zokinvy for HGPS
The FDA has approved ZokinvyTM (lonafarnib; Eiger BioPharmaceuticals) for patients with HGPS. There are approximately 400 cases of HGPS worldwide, with an approximate prevalence of 1 in 20 million people.4
Zokinvy, which inhibits the enzyme responsible for modifying the progerin protein, reduced the mortality rate by 77% among 63 children who were dosed with 150mg/m2 of the medicine twice daily compared with 63 children who were given a placebo in an observational cohort study.4 There were 4 deaths (6.3%) in the Zokinvy group vs 17 deaths (27%) in the placebo group.4
- Xofluza® [package insert]. South San Francisco, CA: Genentech; 2020.
- Keytruda® [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; 2020.
- Brilinta® [package insert]. Wilmington, DE: AstraZeneca; 2020.
- Progeria and Progeroid Laminopathies. Eger BioPharmaceuticals. https://eigerbio.com/progeria-progeroid-laminopathies/ Accessed December 2, 2020.