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Trelegy Ellipta - A Three-Drug Inhaler for COPD
The Medical Letter on Drugs and Therapeutics • May 21, 2018 (Issue 1547)
.
If exacerbations persist with dual therapy, ICS/LAMA/
LABA triple therapy should be used.1,2
CLINICAL STUDIES ...
The FDA has approved Trelegy Ellipta (GSK), a fixed-dose
combination of the inhaled corticosteroid (ICS)
fluticasone furoate, the long-acting antimuscarinic
agent (LAMA) umeclidinium, and the long-acting
beta2-agonist (LABA) vilanterol. It is available as a dry
powder inhaler for once-daily maintenance treatment
of COPD and to reduce COPD exacerbations in patients
with a history of exacerbations. Trelegy Ellipta is
the first three-drug inhaler for treatment of COPD to
become available in the US.
Ertugliflozin for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • Apr 23, 2018 (Issue 1545)
as monotherapy or in
addition to other drugs, they reduce A1C by 0.5-1%.
SGLT2 inhibitors also reduce systolic ...
The FDA has approved the sodium-glucose co-transporter
2 (SGLT2) inhibitor ertugliflozin (Merck)
for treatment of adults with type 2 diabetes, both
alone (Steglatro) and in fixed-dose combinations
with metformin (Segluromet) and sitagliptin
(Steglujan). Ertugliflozin is the fourth SGLT2 inhibitor
to be approved in the US. All four are available in
combination with metformin and three are available
in combination with a dipeptidyl peptidase-4 (DPP-4)
inhibitor (see Table 3).
Copanlisib (Aliqopa) for Relapsed Follicular Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 23, 2018 (Issue 1545)
, was the first.1
STANDARD TREATMENT — Treatment options for
relapsed follicular lymphoma include immunotherapy ...
The FDA has granted accelerated approval to copanlisib
(Aliqopa – Bayer), an intravenously administered
phosphatidylinositol 3-kinase (PI3K) inhibitor, for
treatment of adults with relapsed follicular lymphoma
who have received at least two prior systemic
therapies. Follicular lymphoma is a common subtype
of non-Hodgkin's lymphoma. Copanlisib is the second
PI3K inhibitor to be approved for this indication;
idelalisib (Zydelig), which is administered orally twice
daily, was the first.
Ibalizumab-uiyk (Trogarzo) for Multidrug-Resistant HIV
The Medical Letter on Drugs and Therapeutics • Apr 23, 2018 (Issue 1545)
of multidrugresistant
HIV-1 (MDR-HIV) infection in heavily
antiretroviral-experienced adults with treatment
failure ...
The FDA has approved ibalizumab-uiyk (Trogarzo –
Theratechnologies/TaiMed), a CD4-directed monoclonal
antibody, for IV treatment of multidrug-resistant
HIV-1 (MDR-HIV) infection in heavily
antiretroviral-experienced adults with treatment
failure on their current regimen. Ibalizumab-uiyk is
the first biologic drug to be approved by the FDA for
treatment of HIV-1 infection.
Nebulized Glycopyrrolate (Lonhala Magnair) for COPD
The Medical Letter on Drugs and Therapeutics • Apr 23, 2018 (Issue 1545)
with
formoterol (Bevespi Aerosphere).1 Lonhala Magnair is
the first nebulized LAMA to become available ...
The FDA has approved an inhalation solution
formulation of the long-acting antimuscarinic agent
(LAMA) glycopyrrolate (Lonhala Magnair – Sunovion)
for maintenance treatment of chronic obstructive
pulmonary disease (COPD). The new formulation
is delivered using a portable, handheld, electronic
nebulizer. Glycopyrrolate is also available as a dry
powder inhaler, both alone (Seebri Neohaler) and in
combination with indacaterol (Utibron Neohaler),
and as a metered-dose inhaler in combination with
formoterol (Bevespi Aerosphere). Lonhala Magnair is
the first nebulized LAMA to become...
Deutetrabenazine (Austedo) for Huntington's Chorea and Tardive Dyskinesia
The Medical Letter on Drugs and Therapeutics • Apr 23, 2018 (Issue 1545)
dyskinesia.9
Table 1. Pharmacology
Class Vesicular monoamine transporter 2
(VMAT2) inhibitor
Route Oral ...
The FDA has approved deutetrabenazine (Austedo –
Teva), a vesicular monoamine transporter 2 (VMAT2)
inhibitor, for treatment of chorea associated with
Huntington's disease and, more recently, for treatment
of tardive dyskinesia in adults. It is the second VMAT2
inhibitor to be approved for each of these indications;
tetrabenazine (Xenazine, and generics) was approved
earlier for Huntington's chorea and valbenazine
(Ingrezza) was recently approved for treatment of
adults with tardive dyskinesia.
Brigatinib (Alunbrig) for Non-Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Apr 23, 2018 (Issue 1545)
inhibits ALK and other receptor
tyrosine kinases.
Table 1. Pharmacology
Class ALK/ROS1 tyrosine kinase ...
The FDA has approved brigatinib (Alunbrig – Takeda),
an oral tyrosine kinase inhibitor, for treatment of
patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
who have progressed on or are intolerant to crizotinib
(Xalkori). Translocations of the ALK gene are found in
about 5% of lung cancers; they occur predominantly
in nonsmokers with adenocarcinoma. Brigatinib is the
third tyrosine kinase inhibitor to be approved for this
indication; ceritinib (Zykadia) and alectinib (Alecensa)
were approved earlier, and subsequently were...
Delafloxacin (Baxdela) - A New Fluoroquinolone Antibiotic
The Medical Letter on Drugs and Therapeutics • Mar 26, 2018 (Issue 1543)
are excluded from
ABSSSI trials.1
STANDARD TREATMENT — In many parts of the US,
purulent skin and soft ...
The FDA has approved delafloxacin (Baxdela –
Melinta), an anionic fluoroquinolone antibiotic, for oral
and parenteral treatment of adults with acute bacterial
skin and skin structure infections (ABSSSIs), including
those caused by methicillin-resistant Staphylococcus
aureus (MRSA). It is the first fluoroquinolone to be
approved for treatment of MRSA.
Secnidazole (Solosec) for Bacterial Vaginosis
The Medical Letter on Drugs and Therapeutics • Mar 26, 2018 (Issue 1543)
for decades
in many other countries for treatment of BV,
trichomoniasis, and other infections.1
Table 1 ...
The FDA has approved secnidazole oral granules
(Solosec – Symbiomix/Lupin) for single-dose treatment
of bacterial vaginosis (BV) in adult women.
Voretigene Neparvovec-rzyl (Luxturna) for Inherited Retinal Dystrophy
The Medical Letter on Drugs and Therapeutics • Mar 26, 2018 (Issue 1543)
in young adulthood.1
No effective treatments have been available. The
Argus II Retinal Prosthesis System ...
The FDA has approved voretigene neparvovec-rzyl
intraocular suspension (Luxturna – Spark), an
adeno-associated virus vector-based gene therapy,
for treatment of confirmed biallelic RPE65 mutation-associated
retinal dystrophy in patients who have viable
retinal cells. It is the first gene replacement therapy
approved in the US that targets a disease caused by
mutations in a specific gene and the first pharmacologic
treatment to be approved for this disorder.