Setmelanotide (Imcivree) for Rare Genetic Forms of Obesity (online only)
Date: July 26, 2021
Issue #:
1629Summary:
The FDA has approved setmelanotide (Imcivree–
Rhythm), a subcutaneously injected melanocortin 4
(MC4) receptor agonist, for chronic weight management
in patients ≥6 years old with obesity due to
pro-opiomelanocortin (POMC) deficiency, proprotein
subtilisin/kexin type 1 (PCSK1) deficiency, or leptin
receptor (LEPR) deficiency. (Source: The Medical Letter)
Source: The Medical Letter - July 14, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
In Brief: Risdiplam (Evrysdi) for Spinal Muscular Atrophy (online only)
Date: July 26, 2021
Issue #:
1629Summary:
Risdiplam (Evrysdi– Genentech), a survival of motor
neuron 2 (SMN2) splicing modifier, has been approved
by the FDA for oral treatment of spinal muscular
atrophy (SMA) in patients ≥2 months old. It is the first
oral drug to be approved in the US for treatment of
SMA; nusinersen(Spinraza), an intrathecally administered
SMN2-directed antisense oligonucleotide,
and onasemnogene abeparvovec(Zolgensma), an IV
adeno-associated virus vector-based gene therapy,
were approved earlier. (Source: The Medical Letter)
Source: The Medical Letter - July 14, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Fenfluramine (Fintepla) for Dravet Syndrome
Date: August 9, 2021
Issue #:
1630Summary:
The FDA has approved fenfluramine oral solution
(Fintepla– Zogenix) for treatment of seizures in
patients ≥2 years old with Dravet syndrome. It is the
third drug to be approved for this indication. Stiripentol(Diacomit) and cannabidiol(Epidiolex), a purified
product derived from marijuana, were approved earlier. (Source: The Medical Letter)
Source: The Medical Letter - July 13, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Addendum: Aducanumab (Aduhelm) for Alzheimer's Disease
Date: July 26, 2021
Issue #:
1629Summary:
In June 2021, the FDA approved the IV amyloid beta-directed
monoclonal antibody aducanumab(Aduhelm) for treatment
of Alzheimer ’s disease. The approval did not restrict use of
the drug to patients with mild cognitive impairment or mild
dementia, which was the population enrolled in the clinical
trials. Now, Biogen, with the permission of the FDA, has made
an addition to the labeling of the drug that says:Treatment with
Aduhelm should be initiated in patients with mild cognitive
impairment or mild dementia stage of disease, the populatio...
Source: The Medical Letter - July 9, 2021 Category: Drugs & Pharmacology Authors: admin Tags: aducanumab Aduhelm Alzheimer ' s disease Source Type: research
In Brief: Dapagliflozin (Farxiga) for Chronic Kidney Disease
Date: July 26, 2021
Issue #:
1629Summary:
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
dapagliflozin (Farxiga– AstraZeneca) has been
approved by the FDA for treatment of adults with
chronic kidney disease (CKD) at risk of progression
(not defined in the label). Dapagliflozin is the first
SGLT2 inhibitor to be approved in the US for treatment
of CKD. (Source: The Medical Letter)
Source: The Medical Letter - July 9, 2021 Category: Drugs & Pharmacology Authors: admin Tags: chronic kidney disease dapagliflozin Farxiga Forxiga Source Type: research
An EUA for Tocilizumab (Actemra) for COVID-19
Date: July 26, 2021
Issue #:
1629Summary:
The interleukin-6 (IL-6) receptor antagonist
tocilizumab (Actemra– Genentech) has received an
Emergency Use Authorization (EUA) from the FDA for
IV treatment of COVID-19 in hospitalized patients ≥2
years old who are receiving a systemic corticosteroid
and require supplemental oxygen, mechanical
ventilation, or extracorporeal membrane oxygenation
(ECMO). Tocil izumab has been approved by the FDA
for various indications, including rheumatoid arthritis
and juvenile idiopathic arthritis. (Source: The Medical Letter)
Source: The Medical Letter - July 9, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Actemra baricitinib corticosteroids COVID-19 Dexamethasone Olumiant remdesivir Tocilizumab Source Type: research
Ponesimod (Ponvory) for Multiple Sclerosis
Date: August 9, 2021
Issue #:
1630Summary:
The FDA has approved ponesimod (Ponvory–
Janssen), a sphingosine 1-phosphate (S1P) receptor
modulator, for treatment of adults with relapsing forms
of multiple sclerosis (MS), including clinically isolated
syndrome (initial neurological episode), relapsing-remitting
disease, and active secondary progressive
MS (SPMS). Ponesimod is the fourth oral S1P receptor
modulator to be approved in the US for once-daily
treatment of relapsing forms of MS; ozanimod(Zeposia) and siponimod(Mayzent) are also approved
for use in adults, and fingolimod(...
Source: The Medical Letter - June 29, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Myfembree for Fibroid-Associated Heavy Menstrual Bleeding
Date: August 9, 2021
Issue #:
1630Summary: Myfembree (Myovant/Pfizer), an oral fixed-dose
combination of the gonadotropin-releasing hormone
(GnRH) receptor antagonist relugolix, the estrogen
estradiol, and the progestin norethindrone acetate,
has been approved by the FDA for management of
heavy menstrual bleeding associated with uterine
leiomyomas (fibroids) in premenopausal women. It is
the second product to be approved in the US for this
indication;Oriahnn, which contains the GnRH receptor
antagonist elagolix in combination with estradiol and
norethindrone acetate, was approved earlier. R...
Source: The Medical Letter - June 29, 2021 Category: Drugs & Pharmacology Authors: admin Source Type: research
Sunscreens
Date: July 26, 2021
Issue #:
1629Summary:
Excessive exposure to ultraviolet (UV) radiation
is associated with sunburn, photoaging, and skin
cancer. Sunscreens are widely used to reduce these
risks, but questions remain about their effectiveness
and safety. The FDA has issued a proposed rule that
would require manufacturers to perform additional
safety studies for some sunscreen active ingredients
and would mandate better UVA protection in
sunscreen products. Some sunscreen products
containing FDA-approved active ingredients are
listed in Table 2. (Source: The Medical Letter)
Source: The Medical Letter - June 15, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Insect repellents Melanoma skin cancer sunscreens Vitamin D Source Type: research
Semaglutide (Wegovy) for Weight Loss
Date: July 12, 2021
Issue #:
1628Summary:
The injectable glucagon-like peptide-1 (GLP-1)
receptor agonist semaglutide, previously approved
by the FDA asOzempic to treat type 2 diabetes and
to reduce the risk of major adverse cardiovascular
events in adults with type 2 diabetes and established
cardiovascular disease, has now been approved in
a higher dose asWegovy (Novo Nordisk) for chronic
weight management in adults with or without type 2
diabetes who have a body mass index (BMI) ≥30 kg/m2
or a BMI ≥27 kg/m2 and ≥1 weight-related comorbidity
(e.g., hypertension, dyslipidem...
Source: The Medical Letter - June 15, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Liraglutide Phentermine Qsymia Saxenda semaglutide topiramate type 2 diabetes Wegovy Weight loss Source Type: research
Aducanumab (Aduhelm) for Alzheimer's Disease
Date: July 12, 2021
Issue #:
1628Summary:
Aducanumab-avwa (Aduhelm– Biogen/Eisai), an
IV amyloid beta-directed monoclonal antibody,
has received accelerated approval from the FDA
for treatment of Alzheimer ' s disease. The approval
was based on the surrogate endpoint of reduction in
amyloid beta plaques in the brain. The manufacturer
is required to conduct an additional randomized
controlled trial to establish that reducing amyloid
beta plaques with aducanumab improves clinical
outcomes in patients with Alzheimer ' s disease. (Source: The Medical Letter)
Source: The Medical Letter - June 15, 2021 Category: Drugs & Pharmacology Authors: admin Tags: aducanumab Aduhelm Alzheimer ' s disease Donepezil Galantamine Memantine Rivastigmine Source Type: research
Casimersen (Amondys 45) for Duchenne Muscular Dystrophy (online only)
Date: June 28, 2021
Issue #:
1627Summary:
Casimersen (Amondys 45– Sarepta), an IV antisense
oligonucleotide, has received accelerated approval
from the FDA for treatment of Duchenne muscular
dystrophy (DMD) in patients who have mutations
of the dystrophin gene that are amenable to exon
45 skipping (DMD-45), which occur in ~8% of DMD
cases. Casimersen is the fi rst drug to be approved
for this indication and the fifth to be approved for
treatment of DMD; the IV antisense oligonucleotides
eteplirsen(Exondys 51), golodirsen(Vyondys 53),
and viltolarsen(Viltepso) and the oral corti...
Source: The Medical Letter - June 15, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Amondys 45 casimersen deflazacort Duchenne muscular dystrophy Emflaza eteplirsen Exondys 51 golodirsen Viltepso viltolarsen Vyondys 53 Source Type: research
Jatenzo - An Oral Testosterone for Hypogonadism
Date: June 28, 2021
Issue #:
1627Summary:
An oral formulation of testosterone undecanoate
(Jatenzo– Clarus) has been approved by the FDA for
treatment of adult men with conditions associated
with a deficiency of endogenous testosterone, such as
Klinefelter syndrome, orchiectomy, toxic damage from
chemotherapy or alcohol, or pituitary-hypothalamic
injury from tumors, trauma, or radiation.Jatenzo is
not approved for treatment of low testosterone levels
solely due to aging. It is the first oral testosterone
formulation to be approved in the US. (Source: The Medical Letter)
Source: The Medical Letter - June 10, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Androderm AndroGel Aveed Delatestryl Depo-Testosterone Fortesta Hypogonadism Jatenzo Natesto Testim Testopel Xyosted Source Type: research
Insect Repellents
Date: July 12, 2021
Issue #:
1628Summary:
The Centers for Disease Control and Prevention
(CDC) and the Environmental Protection Agency
(EPA) recommend using insect repellents to prevent
infections transmitted by mosquitoes and ticks.
Insect repellents applied to exposed skin should be
used in conjunction with other preventive measures
such as wearing pants and long-sleeved shirts and
avoiding outdoor activities during peak mosquito-biting
times. Mosquitoes can transmit diseasecausing
pathogens, including Zika, chikungunya,
dengue, West Nile, eastern equine encephalitis, and
yello...
Source: The Medical Letter - June 1, 2021 Category: Drugs & Pharmacology Authors: admin Tags: Deet Dengue icaridin Insect repellents Lyme disease Malaria nootkatone Permethrin Picaridin Zika Source Type: research
An EUA for Sotrovimab for Treatment of COVID-19
Date: June 28, 2021
Issue #:
1627Summary:
The investigational monoclonal antibody sotrovimab
(VIR-7831; GSK/Vir Biotechnology) has been granted
an FDA Emergency Use Authorization (EUA) for
treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high
risk of progressing to severe disease, including
hospitalization and death.1 Two other monoclonal
antibody regimens are authorized for the same
indication: casirivimab (REGN10933) and imdevimab
(REGN10987) administered together, and bamlanivima b (LY-CoV555) and etesevimab (LYCoV016)
adm...
Source: The Medical Letter - June 1, 2021 Category: Drugs & Pharmacology Authors: admin Tags: bamlanivimab casirivimab COVID-19 etesevimab imdevimab sotrovimab Source Type: research
