Inclisiran (Leqvio) for LDL-Cholesterol Lowering
Date: March 21, 2022
Issue #:
1646Summary:
The FDA has approved inclisiran (Leqvio– Novartis),
a small interfering RNA (siRNA) directed to proprotein
convertase subtilisin/kexin type 9 (PCSK9) mRNA,
as an adjunct to diet and maximally tolerated statin
therapy for subcutaneous (SC) treatment of adults
with heterozygous familial hypercholesterolemia
(HeFH) or clinical atheroscler otic cardiovascular
disease (ASCVD) who require additional lowering
of low-density lipoprotein cholesterol (LDL-C).
Inclisiran is the first FDA-approved PCSK9-directed
siRNA therapeutic agent. (Source: The Medical Letter)
Source: The Medical Letter - February 8, 2022 Category: Drugs & Pharmacology Authors: admin Tags: alirocumab bempedoic acid evolocumab Ezetimibe Ezetrol Hypercholesterolemia inclisiran Leqvio Nexletol Nexlizet Praluent Repatha Statins Zetia Source Type: research
Nonopioid Drugs for Pain
Date: March 7, 2022
Issue #:
1645Summary:
Nonopioid drugs can be used in the treatment of
many nociceptive and neuropathic pain conditions.
For severe pain, especially severe chronic cancer
pain, use of opioids may be necessary. Noninvasive
nonpharmacologic treatments, including physical
and psychological therapies, have been shown to
improve pain and function in patients with some
common chronic pain conditions and are unlikely
to cause serious harms. A multimodal approach to
analgesic therapy can increase pain control while
reducing opioid use and adverse effects. (Source: The Medical Letter)
Source: The Medical Letter - February 8, 2022 Category: Drugs & Pharmacology Authors: admin Source Type: research
Odevixibat (Bylvay) for Progressive Familial Intrahepatic Cholestasis-Associated Pruritus
Date: February 21, 2022
Issue #:
1644Summary:
Odevixibat (Bylvay– Albireo), an oral ileal bile acid
transporter (IBAT) inhibitor, has been approved by the
FDA for treatment of pruritus in patients ≥3 months
old with progressive familial intrahepatic cholestasis
(PFIC). It is the first drug to be approved in the US for
this indication. (Source: The Medical Letter)
Source: The Medical Letter - February 4, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Actigall Antihistamines Bylvay Naltrexone odevixibat Rifampin Urso ursodeoxycholic acid Ursodiol Source Type: research
COVID-19 Updates
Date: February 21, 2022
Issue #:
1644Summary:
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to moderate
COVID-19 in outpatients ≥12 years old who weigh
≥40 kg and are at high risk for progression to severe
disease, including hospitaliz ation or death; they
also issued an Emergency Use Authorization (EUA)
allowing its use in any other high-risk outpatient who
weighs ≥3.5 kg. (Source: The Medical Letter)
Source: The Medical Letter - January 28, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Comirnaty COVID-19 nirmatrelvir Paxlovid remdesivir Ritonavir sotrovimab Spikevax Vaxzevria Viklury Source Type: research
Cabotegravir (Apretude) for HIV-1 Pre-Exposure Prophylaxis
Date: February 21, 2022
Issue #:
1644Summary:
The FDA has approvedApretude (ViiV Healthcare),
an IM extended-release (ER) formulation of the integrase
strand transfer inhibitor (INSTI) cabotegravir,
for use every 2 months to prevent sexually acquired
HIV-1 infection in at-risk adolescents and adults.Apretude is the first ER formulation to be FDA-approved
for pre-exposure prophylaxis (PrEP) of
HIV-1 infection. (Source: The Medical Letter)
Source: The Medical Letter - January 25, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Actigall Antihistamines Bylvay Naltrexone odevixibat Rifampin Urso ursodeoxycholic acid Ursodiol Source Type: research
Remimazolam (Byfavo) for Short-Term Procedural Sedation
Date: February 21, 2022
Issue #:
1644Summary:
The FDA has approved remimazolam (Byfavo– Acacia
Pharma), an ultra-short-acting IV benzodiazepine,
for induction and maintenance of sedation in adults
undergoing procedures of up to 30 minutes ' duration. (Source: The Medical Letter)
Source: The Medical Letter - January 25, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Byfavo Midazolam propofol Remimazolam Source Type: research
Tezepelumab (Tezspire) for Severe Asthma
Date: February 21, 2022
Issue #:
1644Summary:
Tezepelumab-ekko (Tezspire– AstraZeneca/Amgen),
a subcutaneously administered thymic stromal
lymphopoietin (TSLP) blocker, has been approved
by the FDA for add-on maintenance treatment of
severe asthma in patients ≥12 years old. It is the first
TSLP blocker to become available in the US and the
first biologic drug to be approved for treatment
of severe asthma without phenotypic or biomarker
limitations. (Source: The Medical Letter)
Source: The Medical Letter - January 25, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Asthma dupilumab Dupixent mepolizumab Nucala tezepelumab Tezspire Source Type: research
Glycopyrrolate (Dartisla ODT) for Peptic Ulcer Symptoms
Date: February 7, 2022
Issue #:
1643Summary:
The FDA has approved adjunctive treatment withDartisla ODT (Edenbridge), a new orally disintegrating
tablet (ODT) formulation of the anticholinergic drug
glycopyrrolate, to reduce symptoms of a peptic ulcer.
Glycopyrrolate oral tablets (Robinul, Robinul Forte,
and generics) were approved for the same indication
in 1961. (Source: The Medical Letter)
Source: The Medical Letter - January 21, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Dartisla Glycopyrrolate Peptic ulcer disease Proton pump inhibitors Robinul Source Type: research
Lonapegsomatropin (Skytrofa) for Growth Hormone Deficiency
Date: February 7, 2022
Issue #:
1643Summary:
Lonapegsomatropin-tcgd (Skytrofa– Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for
once-weekly subcutaneous (SC) treatment of growth
failure due to inadequate secretion of endogenous
growth hormone in children≥1 year old who weigh≥11.5 kg. It is the first once-weekly rhGH product to be
approved in the US; other available rhGH formulations
are administered more frequently. (Source: The Medical Letter)
Source: The Medical Letter - January 21, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Genotropin Growth hormone Humatrope lonapegsomatropin Norditropin Nutropin Omnitrope Saizen Skytrofa Zomacton Source Type: research
Difelikefalin (Korsuva) for Chronic Kidney Disease-Associated Pruritus
Date: February 7, 2022
Issue #:
1643Summary:
Difelikefalin (Korsuva– Vifor), an IV kappa opioid
receptor (KOR) agonist, has been approved by the
FDA for treatment of moderate to severe pruritus
associated with chronic kidney disease (CKD) in
adults on hemodialysis. It is the first drug to be
approved for this indication and the first KOR agonist
to become availab le in the US. Difelikefalin has not
been studied in patients on peritoneal dialysis. (Source: The Medical Letter)
Source: The Medical Letter - January 11, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Antihistamines chronic kidney disease difelikefalin Gabapentin Korsuva Lyrica Montelukast Neurontin Phototherapy Pregabalin sertraline Singulair Zoloft Source Type: research
Vuity - Pilocarpine Ophthalmic Solution for Presbyopia
Date: February 7, 2022
Issue #:
1643Summary:
The FDA has approvedVuity (Abbvie), a 1.25%
ophthalmic solution of the muscarinic receptor
agonist pilocarpine hydrochloride, for treatment of
presbyopia in adults. Pilocarpine 1%, 2%, and 4%
ophthalmic solutions (Isopto Carpine, and others)
have been available for years for treatment of
glaucoma, but local and systemic adverse effects
have limited their use. (Source: The Medical Letter)
Source: The Medical Letter - January 11, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Eye isopto carpine Pilocarpine Vuity Source Type: research
Molnupiravir for Treatment of COVID-19
Date: January 24, 2022
Issue #:
1642Summary:
The investigational oral antiviral drug molnupiravir
(Merck/Ridgeback Biotherapeutics) was granted an
FDA Emergency Use Authorization (EUA) on December
23, 2021 for treatment of mild to moderate COVID-19
in outpatients≥18 years old who are at high risk of
progressing to severe disease, including hospitalization
or death (see Table 1), and for whom alternative treatment options are
not available or clinically appropriate.Paxlovid (Pfizer),
nirmatrelvir copackaged with ritonavir, was granted
an EUA on December 22, 2021. The IV antivir...
Source: The Medical Letter - January 7, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Antiviral drugs COVID-19 molnupiravir Source Type: research
COVID-19 Updates
Date: January 24, 2022
Issue #:
1642Summary:
On January 3, the FDA amended its Emergency
Use Authorization (EUA) for the Pfizer-BioNTech
COVID-19 vaccine(Comirnaty) to incorporate the
following changes. The anti-SARS-CoV-2 antibody combinations
casirivimab plus imdevimab(REGEN-COV) and
bamlanivimab plus etesevimab are not active
against the Omicron variant of SARS-CoV-2. (Source: The Medical Letter)
Source: The Medical Letter - January 7, 2022 Category: Drugs & Pharmacology Authors: admin Tags: bamlanivimab casirivimab Comirnaty COVID-19 etesevimab imdevimab REGEN-COV sotrovimab Spikevax vaccines Source Type: research
In Brief: Mifepristone by Mail for Pregnancy Termination
Date: January 24, 2022
Issue #:
1642Summary:
The FDA has removed the requirement that
mifepristone (Mifeprex, and generics), a progestin
receptor antagonist approved for use in a regimen with
the prostaglandin E1 analog misoprostol (Cytotec,
and generics) for medical termination of pregnancy,
must be dispensed in person to the patient. (Source: The Medical Letter)
Source: The Medical Letter - January 7, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Mifegymiso Mifeprex Mifepristone Source Type: research
Paxlovid for Treatment of COVID-19
Date: January 24, 2022
Issue #:
1642Summary:
On December 22, 2021, the FDA issued an Emergency
Use Authorization (EUA) for the investigational
antiviral drug nirmatrelvir copackaged with the HIV-1
protease inhibitor ritonavir (Paxlovid– Pfizer) for
oral treatment of mild to moderate COVID-19 in
outpatients≥12 years old who weigh at least 40 kg
and are at high risk of progressing to severe disease,
including hospitalization or death.Paxlovid was the
first oral antiviral drug to be authorized in the US for
treatment of COVID-19; Merck ' s oral antiviral drug
molnupiravir was g...
Source: The Medical Letter - January 7, 2022 Category: Drugs & Pharmacology Authors: admin Tags: Antiviral drugs COVID-19 molnupiravir nirmatrelvir Paxlovid remdesivir Ritonavir Veklury Source Type: research
