Livtencity (maribavir)
Maribavir is an antiviral that elicits its activity by competitive inhibition of the protein kinase activity of human cytomegalovirus (CMV) enzyme pUL97, which inhibits protein phosphorylation. It is indicated for treatment of posttransplant CMV infection/disease that is refractory to treatment with or without genotypic resistance (eg, ganciclovir, valganciclovir, cidofovir, foscarnet) in adults and pediatric patients aged 12 years and older who weigh at least 35 kg.
The phase 3 SOLSTICE trial randomized hematopoietic-cell and solid-organ transplant recipients 2:1 to receive maribavir (n = 235) or investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir [n = 117]). Significantly more patients in the maribavir versus IAT group achieved CMV clearance by week 8 (55.7% vs 23.9%; P<.001) and maintained through week 16 (18.7% vs 10.3%; P=.01). Clin Infect Dis. 2021 Dec 2
Comirnaty (COVID-19 vaccine, mRNA-Pfizer)
COVID-19 vaccine, mRNA-Pfizer is the first vaccine to gain full approval in the United States for prevention of COVID-19 disease for individuals aged 16 years and older. Since its August 2021 approval, the emergency use authorization for the vaccine has been amended to include children aged 5 years and older, third-dose administration for those aged 12 years and older who are immunocompromised, and booster doses for individuals aged 16 years and older.
Approval was based on a multinational phase 3 trial (n = 43,448). Vaccine efficacy was 95% against the original SARS-CoV-2 strain at 7 days after dose 2, and no serious safety concerns were observed. Updated data through 6 months (March 13, 2021) showed vaccine efficacy against COVID-19 was 91.3%. Vaccine variants (eg, delta) and waning efficacy prompted implementation of adding a booster dose to be administered 6 months after the 2-dose primary series. N Engl J Med 2021;385:1761-1773
Vaxneuvance and Prevnar 20 (15-valent and 20-valent pneumococcal vaccines)
Pneumococcal vaccine 15-valent and pneumococcal vaccine 20-valent contain all serotypes in the 13-valent pneumococcal vaccine, plus additional serotypes responsible for pneumococcal disease cases and deaths in the United States. Each vaccine is indicated for active immunization for prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae in adults aged 18 years and older.
Additional serotypes in the pneumococcal vaccine 15-valent include 22F and 33F.
Additional serotypes in pneumococcal vaccine 20-valent include 8, 10A, 11A, 12F, 15B, 22F, and 33F.
The CDC Pneumococcal Vaccines Work Group has issued a working document on how the newest pneumococcal vaccines are planned to be incorporated into the adult immunization schedule.
TicoVac (tick-borne encephalitis vaccine)
Tick-borne encephalitis vaccine is indicated in adults and children aged 1 year and older for prevention of tick-borne encephalitis caused by Flaviviridae, including European or Western tick-borne encephalitis virus (transmitted by Ixodes ricinus), Siberian tick-borne encephalitis virus (transmitted by I persulcatus), and Far-Eastern tick-borne encephalitis virus, formerly known as Russian spring-summer encephalitis virus (transmitted by I persulcatus). It is administered as a 3-dose primary series.
Seropositivity rates at Day 21 after the third vaccination were above 99% for all age groups in Study 209 and above 98% in Study 213 and Study 690601. Three years after the primary 3-dose series, seropositivity ranged from 82.9 to 100% depending on age. Prescribing Information
Fexinidazole
Fexinidazole is a nitroimidazole antiprotozoal drug indicated for treatment of African trypanosomiasis (HAT; sleeping sickness) caused by Trypanosoma brucei gambiense in adults and children aged 6 years and older who weigh at least 20 kg. It is indicated for stage 1 (hemolymphatic) and stage 2 (meningoencephalitic) HAT.
Results from 2 single-arm trials in adults and pediatric patients aged 6-15 years supported FDA approval. Fexinidazole demonstrated efficacy of nearly 100% at 12 months. Lancet Glob Health. 2021 Jul;9(7)
Cabenuva (cabotegravir/rilpivirine) and Vocabria (cabotegravir)
Cabotegravir/rilpivirine is a combination of HIV-1 integrase strand transfer inhibitor (INSTI) and non-nucleoside reverse transcriptase inhibitor (NNRTI), which are copackaged as 2 separate intramuscular (IM) injections. Cabotegravir/rilpivirine is indicated as a complete regimen for treatment of HIV-1 infection in adults to replace a current stable antiretroviral therapy regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. It is initiated as a once-monthly IM injection following lead-in therapy with oral cabotegravir (Vocabria) plus rilpivirine (Edurant) for a least 1 month.
The safety and efficacy of cabotegravir/rilpivirine were established through 2 randomized, open-label, controlled clinical trials in 1182 HIV-infected adults who were virologically suppressed (HIV-1 RNA <50 copies/mL) before initiation of the treatment. Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed. N Engl J Med. 2020 Mar 19;382(12):1112-1123 ; N Engl J Med. 2020 Mar 19;382(12):1124-1135
Tembexa (brincidofovir)
Brincidofovir is a prodrug of cidofovir. Brincidofovir effectively penetrates cells via its lipid conjugate, releasing the nucleotide analog cidofovir, which then acts to inhibit viral replication. Cidofovir diphosphate selectively inhibits orthopoxvirus DNA polymerase–mediated viral DNA synthesis by incorporation of cidofovir into the growing viral DNA chain. This results in reductions in the rate of viral DNA synthesis. It is indicated for treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates.
The drug gained approval under the FDA's animal rule. Approval was based on efficacy data in 2 lethal orthopoxvirus animal models of human smallpox disease: the rabbit pox model (New Zealand white rabbits infected with rabbit pox virus) and the mouse pox model (BALB/c mice infected with ectromelia virus). In the pivotal studies in each model, brincidofovir resulted in statistically significant survival benefit versus placebo following delayed treatment after animals were infected with a lethal viral dose. Tembexa prescribing information
Other infectious disease approvals
Apretude (cabotegravir) - Every 2 month IM administration for preexposure prophylaxis (PrEP) in adults and adolescents weighing at least 35 kg to reduce the risk of sexually acquired HIV-1 infection.
Solosec (secnidazole) - New indication approved for treatment of trichomoniasis, to treat partners of infected patients simultaneously in order to prevent reinfection.
Shingrix (zoster vaccine recombinant) - Indication for shingles immunization expanded to include adults aged 18 years and older with increased risk of herpes zoster owing to immunodeficiency or immunosuppression caused by a known disease or therapy.
Natroba (spinosad) - New indication approved for scabies in adults and children aged 4 years and older.
Vaxchora (cholera vaccine) - Use for immunization against Vibrio cholerae serogroup 01 expanded to include children aged 2 years and older.
Rapivab (peramivir) - Indication for acute uncomplicated influenza expanded to include children as young as 6 months.
COVID-19 Emergency Use Authorizations
Oral antivirals
Molnupiravir : Treatment of mild-to-moderate COVID-19 in high-risk adults who test positive.
Paxlovid (nirmatrelvir/ritonavir) : Treatment of mild-to-moderate COVID-19 in high-risk adults and adolescents aged 12 years and older who test positive.
Vaccines
Booster dose authorized for adults aged 18 years and older at least 5 months after an mRNA vaccine or at least 2 months after the Janssen vaccine.
Third primary-series dose at least 1 month after second dose in adults who have undergone solid-organ transplantation or have a condition considered to have equivalent level of immunocompromise.
Booster dose authorized for individuals aged 18 years and older at least 5 months after an mRNA vaccine or at least 2 months after the Janssen vaccine.
Homologous booster dose authorized for adolescents aged 12-17 years at least 5 months after their primary 2-dose series with the Pfizer COVID-19 vaccine (not for heterologous use in this age group).
2-dose primary series approved for children aged 5 years and older.
Third primary-series dose at least 1 month after second dose in individuals aged 5 years and older who have undergone solid-organ transplantation or have a condition considered to have equivalent level of immunocompromise.
COVID-19 vaccine-Janssen (Johnson & Johnson)
Booster dose authorized for adults aged 18 years and older at least 2 months after completing primary vaccination with the Janssen vaccine.
Heterologous booster authorized in adults at least 5 months after receiving an mRNA vaccine.
Monoclonal antibodies
Treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in high-risk adults and children, including neonates.
Postexposure prophylaxis for high-risk adults and children, including neonates who are not fully vaccinated or are not expected to mount an adequate immune response.
REGEN-COV (casirivimab/imdevimab)
Treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in high-risk individuals aged 12 years and older.
Postexposure prophylaxis (PEP) for high-risk individuals aged 12 years and older who are not fully vaccinated or are not expected to mount an adequate immune response.
Treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in high-risk individuals aged 12 years and older.
Evusheld (tixagevimab and cilgavimab)
Preexposure prophylaxis of individuals aged 12 years and older who are moderately-to-severely immunocompromised owing to a medical condition or medications/treatment and may not mount an adequate immune response to COVID-19 vaccination or who have a history of severe adverse reactions to a COVID-19 vaccine and/or component(s)
Note: Depending on viral variants, distribution of certain monoclonal antibodies may be paused because of decreased efficacy.
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Cite this: FDA Approvals, Highlights, and Summaries: Infectious Disease - Medscape - Feb 17, 2022.
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