FDA Drug Approvals, Hospitalists — 2020 Midyear Review

August 14, 2020

Infectious Disease

Rukobia (fostemsavir)

Fostemsavir, a prodrug of temsavir, is a first-in-class glycoprotein 120 (gp120) attachment inhibitor. It binds directly to the gp120 subunit on the surface of the virus, and thereby blocks HIV from attaching to host immune system CD4+ T cells and other immune cells. It is indicated in combination with other antiretroviral drugs for treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection in whom their current antiretroviral regimen failed because of resistance, intolerance, or safety considerations.

Approval was based on the BRIGHTE study (n=371 [including 99 participants in the nonrandomized cohort]). All participants had a viral load of 400 copies/mL or greater and 2 or fewer classes of antiretrovirals remaining at baseline. On day 8, participants treated with fostemsavir (n=203) had a significantly greater decrease in levels of HIV-RNA in their blood compared with those taking the placebo (n=69) (0.79 vs 0.17 log10 copies/mL decline, respectively; P <.0001). After day 8, all participants received fostemsavir with other antiretrovirals. After 24 weeks of fostemsavir plus other antiretrovirals, 53% achieved HIV-RNA suppression, where levels of HIV were low enough to be considered undetectable. After 96 weeks, 60% continued to have HIV-RNA suppression.

( N Engl J Med 2020 Mar 26;382(13):1232-1243 )


Artesunate is an antimalarial artemisinin derivative. It is rapidly metabolized to the active metabolite, dihydroartemisinin (DHA). Artesunate and DHA, like other artemisinins, contain an endoperoxide bridge that is activated by heme iron that leads to oxidative stress, inhibition of protein and nucleic acid synthesis, ultrastructural changes, and decreased parasite growth and survival. Artesunate and DHA are active against the blood-stage asexual parasites and gametocytes of Plasmodium species, including the chloroquine-resistant strains.

Artesunate is administered intravenously and is indicated for adults and children for initial treatment of severe malaria. It should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.

Artesunate IV was officially approved by the FDA in May 2020 (it was previously available from the CDC through an Investigative New Drug protocol). Approval was based the South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) and the African Quinine Artesunate Malaria Trial (AQUAMAT). These 2 studies examined a total of 6886 patients and included adults, children, and pregnant women. Artesunate IV reduced mortality by 34.7% (P=.0002) and 22.5% (P=.002) compared with quinine in the SEAQUMAT and AQUAMAT studies, respectively.

(Lancet 2005 Aug 27-Sep 2;366(9487):717-25

Lancet 2010 Nov 13;376(9753):1647-57 )


Other infectious disease approvals

Epclusa (sofosbuvir/velpatasvir) - Indicated for chronic hepatitis C virus infection in children aged 6 years or older or weighing at least 17 kg.

Recarbrio (imipenem/cilastatin/relebactam) - New indication for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia .

Remdesivir - FDA granted an emergency use authorization for remdesivir to treat hospitalized patients with suspected or confirmed SARS CoV-2 infection and severe COVID-19 disease.

Sirturo (bedaquiline) - Indication for multidrug-resistant pulmonary tuberculosis expanded to include children aged 5 years or older.

Sivextro (tedizolid) - Indicated for acute bacterial skin and skin structure infections in patients aged 12 years or older.

Tivicay PD (dolutegravir) - Indicated for HIV infection in children aged 4 weeks or older who weigh at least 3 kg.

Zosyn (piperacillin/tazobactam) - Indication for nosocomial pneumonia expanded to include children as young as 2 months.


Byfavo (remimazolam)

Remimazolam is a short-acting benzodiazepine for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

Approval was supported by studies of patients undergoing colonoscopy or bronchoscopy. Patients who received remimazolam had a higher total success rate for each of the procedures (80.6-91.3%) compared with placebo (1.7-4.8%). A lower incidence of rescue sedative medication was taken with remimazolam (3.4-15.8%) compared with placebo (90.5-95%). Additionally, the total amount of fentanyl and midazolam rescue medication needed during the procedure was less with remimazolam compared with placebo.

(Byfavo prescribing information)

Barhemsys (amisulpride)

Amisulpride is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist. D2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings. Activation of the CTZ relays stimuli to the vomiting center, which is involved in emesis. It is indicated for prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. It is also indicated for treatment of PONV in adults who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

In a randomized, double-blind, placebo-controlled study involving patients in whom the most commonly used antiemetic prophylaxis had failed, a single 10-mg dose of amisulpride (n=230) was significantly more effective than placebo (n=235) at treating patients (42% vs 29%; P=.003). In a randomized, double-blind, placebo-controlled trial for patients at the highest risk of developing PONV (Apfel score 3 or 4), a single 5-mg dose of amisulpride in combination with another antiemetic (n=572) significantly improved protection from PONV compared with placebo plus another antiemetic (n=575; 58% vs 47%; P <.001).

(Anesthesiology 2019;130(2):203-212

Anesthesiology 2018;128(6):1099-1106 )


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