1
COVID-19 Update: FDA Authorizes Novavax COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has issued an Emergency Use Authorization
(EUA) for an adjuvanted protein subunit COVID-19
vaccine manufactured by Novavax. The vaccine
is indicated for use as a two-dose primary series
to prevent COVID-19 in adults; it is not authorized
for use in children or as a booster dose. Three
other COVID-19 vaccines are available in the US for
primary immunization of adults; the mRNA vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) are FDA-licensed for this indication,
and the adenovirus-based vaccine manufactured
by Johnson & Johnson (Janssen) is available under an
EUA for use in adults who are unable or unwilling to
receive another COVID-19 vaccine.
2
COVID-19 Update: Dosing Interval for Tixagevimab/Cilgavimab (Evusheld) (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has amended its Emergency Use
Authorization (EUA) for the investigational long-acting
monoclonal antibodies tixagevimab and
cilgavimab (Evusheld – AstraZeneca) to recommend
repeat dosing every 6 months in patients who require
ongoing protection against COVID-19. Evusheld
is authorized for IM pre-exposure prophylaxis of
COVID-19 in persons ≥12 years old who weigh ≥40 kg
and have either a history of a severe adverse reaction
that prevents their vaccination against COVID-19 or
moderate or severe immune compromise
3
COVID-19 Update: Prescription of Paxlovid by Pharmacists (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.
4
Drugs for Treatment and Prevention of Venous Thromboembolism
The Medical Letter on Drugs and Therapeutics • July 25, 2022; (Issue 1655)
Anticoagulants are the drugs of choice for treatment
and prevention of deep venous thrombosis (DVT) and
pulmonary embolism (PE), collectively referred to as
venous thromboembolism (VTE). US guidelines for
treatment of VTE were updated in 2020 and 2021.
5
Oteseconazole (Vivjoa) for Recurrent Vulvovaginal Candidiasis
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has approved oteseconazole (Vivjoa –
Mycovia), a new oral azole antifungal, to reduce the incidence
of recurrent vulvovaginal candidiasis (RVVC)
in females with a history of RVVC. Oteseconazole is
the first drug to be approved in the US specifically for
treatment of RVVC.
6
Tapinarof Cream (Vtama) for Psoriasis
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has approved Vtama (Dermavant), a 1%
cream formulation of the aryl hydrocarbon receptor
(AhR) agonist tapinarof, for treatment of adults with
plaque psoriasis. It is the first AhR agonist to be
approved by the FDA.
7
A Donepezil Patch (Adlarity) for Alzheimer's Disease (online only)
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
A once-weekly transdermal formulation of the
acetylcholinesterase inhibitor donepezil (Adlarity –
Corium) has been approved by the FDA for
treatment of mild, moderate, and severe Alzheimer's
disease (AD) dementia. Donepezil is the second
acetylcholinesterase inhibitor to become available in
a transdermal formulation; transdermal rivastigmine
(Exelon Patch), which is applied once daily, has been
available for years for the same indication. Donepezil
is also available in oral formulations (Aricept, and
generics) for treatment of AD dementia.
8
Lumateperone (Caplyta) for Bipolar Depression
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The oral second-generation antipsychotic drug
lumateperone (Caplyta – Intra-Cellular Therapies),
which was approved by the FDA in 2020 for treatment
of schizophrenia, is now approved for use as
monotherapy or as an adjunct to lithium or valproate
for treatment of depressive episodes associated with
bipolar I or II disorder in adults.
9
Comparison Table: Some Parenteral Anticoagulants for VTE (online only)
The Medical Letter on Drugs and Therapeutics • July 25, 2022; (Issue 1655)
View the Comparison Table: Some Parenteral Anticoagulants for VTE
10
Comparison Table: Some Oral Anticoagulants for VTE (online only)
The Medical Letter on Drugs and Therapeutics • July 25, 2022; (Issue 1655)
View the Comparison Table: Some Oral Anticoagulants for VTE