1
In Brief: RSV Vaccine (Arexvy) for Ages 50-59
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The recombinant respiratory syncytial virus (RSV)
vaccine Arexvy (GSK) has now received FDA
approval for use in adults 50-59 years old who
are at increased risk for lower respiratory tract
disease (LRTD) caused by RSV. It was previously
approved only for adults ≥60 years old. Two other
RSV vaccines have received FDA approval: Abrysvo,
a recombinant vaccine that is licensed for use in
adults ≥60 years old and in pregnant women at
32-36 weeks' gestation to prevent RSV-associated
LRTD in their infants, and mResvia, an mRNA vaccine
recently licensed for use in adults ≥60 years old that
will be available for the 2024-25 RSV season.
2
In Brief: Wezlana — An Ustekinumab Biosimilar Interchangeable with Stelara
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The FDA has approved ustekinumab-auub (Wezlana –
Amgen), an interchangeable biosimilar product similar
to the interleukin-12 and -23 antagonist Stelara, for
treatment of the same indications as Stelara (see
Table 1). Wezlana is the first Stelara biosimilar to be
approved in the US.
3
In Brief: Doxycycline for STI Post-Exposure Prophylaxis
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The CDC has issued a recommendation for use
of a single dose of doxycycline for post-exposure
prophylaxis (PEP) of bacterial sexually transmitted
infections (STIs), specifically syphilis, chlamydia, and
gonorrhea, in men who have sex with men (MSM) and
transgender women (TGW) who had a bacterial STI
within the previous 12 months.
4
Iloperidone (Fanapt) — A New Indication for Bipolar Disorder
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The oral second-generation antipsychotic drug
iloperidone (Fanapt – Vanda) has been approved
by the FDA for acute treatment of manic or mixed
episodes associated with bipolar I disorder in adults.
First approved in 2009 for treatment of schizophrenia,
iloperidone is the eighth second-generation antipsychotic
to be approved for acute treatment of manic
or mixed episodes of bipolar I disorder (see Table 1).
5
Iloprost (Aurlumyn) for Frostbite
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The FDA has approved Aurlumyn (Eicos Sciences),
an IV formulation of the prostacyclin analog iloprost,
to reduce the risk of digit amputation in adults
with severe frostbite. Iloprost is the first drug to be
approved by the FDA for treatment of severe frostbite;
it has been used off-label for this indication in the EU
and elsewhere for decades. In the US, iloprost is also
available as an inhaled formulation (Ventavis) for
treatment of pulmonary arterial hypertension.
6
Cefepime/Enmetazobactam (Exblifep) for Complicated Urinary Tract Infections
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The FDA has approved Exblifep (Allecra), a fixed-dose
combination of the cephalosporin cefepime and the
beta-lactamase inhibitor enmetazobactam, for IV
treatment of adults with complicated urinary tract
infections (cUTIs), including pyelonephritis, caused
by designated susceptible microorganisms (see
Spectrum of Activity). Exblifep is the first product that
contains enmetazobactam to be approved in the US.
7
DaxibotulinumtoxinA (Daxxify) for Frown Lines (online only)
The Medical Letter on Drugs and Therapeutics • July 22, 2024; (Issue 1707)
The FDA has approved daxibotulinumtoxinA-lanm
(Daxxify – Revance), an acetylcholine release inhibitor
and neuromuscular blocking agent, for temporary
improvement in the appearance of moderate to severe
glabellar (frown) lines associated with corrugator
and/or procerus muscle activity. Daxxify is the fifth
botulinumtoxin type A product to be approved in the
US for this indication (see Table 1). It is also approved
for treatment of cervical dystonia in adults
8
Drugs for Postmenopausal Osteoporosis
The Medical Letter on Drugs and Therapeutics • July 8, 2024; (Issue 1706)
Pharmacologic treatment is recommended for
postmenopausal women who have bone density
T-scores (standard deviations from normal mean
values in the spine, femoral neck, total hip, or distal
radius) of -2.5 or below, T-scores between -1.0 and
-2.5 with a history of fragility (low-trauma) fracture
of the hip or spine, or T-scores between -1.0 and
-2.5 with a FRAX 10-year probability of ≥3% for hip
fracture or ≥20% for major osteoporotic fracture.
9
Comparison Table: Some Drugs for Postmenopausal Osteoporosis (online only)
The Medical Letter on Drugs and Therapeutics • July 8, 2024; (Issue 1706)
View the Comparison Table: Some Drugs for Postmenopausal Osteoporosis
10
Tarlatamab (Imdelltra) for Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • July 8, 2024; (Issue 1706)
Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class
bispecific delta-like ligand 3 (DLL3)-directed CD3
T-cell engager, has received accelerated approval
from the FDA for treatment of extensive-stage
small cell lung cancer (SCLC) in adults who had
disease progression on or after platinum-based
chemotherapy. It is the first bispecific DLL3-directed
CD3 T-cell engager to be approved in the US for this
indication. Most patients with SCLC have a response
to initial treatment, but progression generally
occurs within a few months and overall survival is
usually less than 8 months. Accelerated approval of
tarlatamab was based on the overall response rate
and duration of response.