The US Food and Drug Administration (FDA) has approved the first-ever treatment options for 2 deadly infectious diseases in October 2020 along with other conditions such as acute myeloid leukemia and pediatric adrenocortical insufficiency. Nurse practitioners (NPs) and physician assistants (PAs) should be aware of advancements in in these fields, specifically the treatments for coronavirus disease 2019 (COVID-19) and Ebola, the infection caused by Zaire ebolavirus.
Veklury for COVID-19
The first FDA-approved treatment for COVID-19, Veklury® (remdesivir; Gilead Sciences), is now available for patients aged 12 years or older, weigh at least 40 kg, and require hospitalization.1 The approval of this drug was supported by 3 clinical trials that demonstrated reduced recovery time for patients hospitalized for COVID-19.
This approval does not include the entire pediatric population that had been authorized to receive Veklury under the Emergency Use Authorization (EUA) issued on May 1, 2020. However, the FDA has revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials for the efficacy of Veklury in this population are ongoing.
Venclexta for Acute Myeloid Leukemia
In combination with azacitidine, or decitabine, or low-dose cytarabine, the FDA has approved Venclexta® (venetoclax; AbbVie) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults aged 75 years and older or adults who cannot be treated with intensive-induction chemotherapy.2
When combined with azacitidine, Venclexta was proven to reduce risk of death by 34% compared with a placebo combination with azacitidine. In addition, more patients in the Venclexta arm achieved complete remission than the placebo arm (27% vs 7.4%).2 The medication is available in 10-mg, 50-mg, and 100-mg tablets.
Inmazeb for Ebola
Both adult and pediatric patients who are infected with the Z ebolavirus can now be treated with Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn; Regeneron), the first approved treatment Ebola.3
The medication is also approved for newborns of mothers who are infected with the virus. Inmazeb will be supplied in single-dose vials containing a solution with 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab-ebgn per 14.5 mL.3
Alkindi Sprinkle for Pediatric Adrenocortical Insufficiency
Since most pediatric patients with adrenocortical insufficiency require less medication than the currently available 5-mg tablet form of hydrocortisone, the FDA has approved Alkindi® Sprinkle (hydrocortisone oral granules; Eton Pharmaceuticals) as a replacement therapy.4
Alkindi Sprinkle is available as oral capsules with inside granules at doses of 0.5 mg, 1 mg, 2 mg, and 5 mg. The capsules should be opened; patients can place the granules directly in their mouth with a spoon, or the granules can be mixed into cold or room temperature soft food and consumed within 5 minutes of removal.
- FDA Approves first treatment for COVID-19 [news release]. Silver Spring, MD: US Food & Drug Administration; October 22, 2020. Accessed October 28, 2020. https://www.prnewswire.com/news-releases/fda-approves-first-treatment-for-covid-19-301158445.html.
- Venclexta® (venetoclax) receives FDA full approval for acute myeloid leukemia (AML) [news release]. North Chicago, IL: AbbVie, Inc; October 16, 2020. Accessed October 28, 2020. https://news.abbvie.com/news/press-releases/venclexta-venetoclax-receives-fda-full-approval-for-acute-myeloid-leukemia-aml.htm
- Regeneron’s antibody cocktail regn-eb3 (Inmazeb®) is first FDA-approved treatment for Ebola (Zaire ebolavirus) [news release]. Tarrytown, NY: Regeneron Pharmaceuticals; October 14, 2020. Accessed October 28, 2020. https://investor.regeneron.com/news-releases/news-release-details/regenerons-antibody-cocktail-regn-eb3-inmazebr-first-fda
- Eton Pharmaceuticals announces FDA approval of orphan drug Alkindi® Sprinkle (hydrocortisone) as replacement therapy in pediatric patients with adrenocortical insufficiency [news release]. Deer Park, IL: Eton Pharmaceuticals; September 29, 2020. Accessed October 28, 2020. https://www.globenewswire.com/news-release/2020/09/29/2101010/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Orphan-Drug-ALKINDI-SPRINKLE-hydrocortisone-as-Replacement-Therapy-in-Pediatric-Patients-with-Adrenocortical-Insufficiency.html.