Article Archives - Page 16 of 21

European Union approved Duvelisib for CLL and Follicular Lymphoma

European Union approval has been recommended for duvelisib (Copiktra) for patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or refractory follicular lymphoma (FL) who have received at least two prior lines of therapy.

Duvelisib is an inhibitor of phosphoinositide 3–kinase (PI3K) and is the first drug to act as a dual inhibitor of PI3K-delta and PI3K-gamma. These enzymes are involved in the proliferation and survival of malignant B-cell lines and primary CLL tumor cells and are involved in immunologic pathways in the tumor microenvironment of malignant B cells.

Duvelisib is already on the market in the United States; it was approved in 2018 for the same two indications and also for use in the treatment of small lymphocytic lymphoma (CLL/SLL).

Clinic Hours In Article, FDA Updates

FDA approves neuromodulation device to improve gait in MS

The US FDA has approved the Portable Neuromodulation Stimulator for the short-term treatment of walking impairments as a result of mild to moderate symptoms from multiple sclerosis (MS).

PoNS is a prescription-only device intended to be used in combination with a supervised therapeutic exercise program in patients aged 22 years and older with MS.

PoNS is a neuromuscular tongue stimulator that generates electrical pulses that stimulate the trigeminal and facial nerves, sending neural impulses to the brain stem, which is thought to enhance neuroplasticity to address motor deficits.

The device’s controller and mouthpiece are connected to each other by a cord. The mouthpiece is held in place by the lips and teeth and the control unit is worn around the neck during a patient’s visit with a therapist.

In a randomized, controlled, double-blind trial involving 20 patients with MS-related gait deficits, 10 patients used the PoNS device and 10 used a sham control device that did not deliver stimulation.

No serious safety adverse events were reported in clinical studies or separate real-world data provided by the company, the FDA said.

The PoNS device should not be used by patients with penetrating brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, unmanaged hypertension or diabetes, pacemakers, and/or a history of seizures.

Source: FDA

Clinic Hours In Article, FDA Updates

FDA approves Transcatheter Pulmonary Valve for Congenital Heart Disease

The US FDA has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System to treat severe pulmonary regurgitation in pediatric and adult patients who have a native or surgically repaired right ventricular outflow tract (RVOT).

The Harmony TPV is the first nonsurgical heart valve to treat severe pulmonary valve regurgitation, which is common in patients with congenital heart disease.

The Harmony valve, which was granted breakthrough device designation, is a 22 mm or 25 mm porcine pericardium valve, sewn to a nitinol frame. It is implanted with a 25-French delivery system using a coil-loading catheter.

The FDA approval was based on the 70-patient prospective, nonrandomized, multicenter Harmony TPV Clinical study, in which 100% of patients achieved the primary safety endpoint of no procedure or device-related deaths 30 days after implantation.

Among 65 patients with evaluable echocardiographic data, 89.2% met the primary effectiveness endpoint of no additional surgical or interventional device-related procedures and acceptable heart blood flow at 6 months.

Adverse events included irregular or abnormal heart rhythms in 23.9% of patients, including 14.1% ventricular tachycardia; leakage around the valve in 8.5%, including 1.4% major leakage; minor bleeding in 7.0%, narrowing of the pulmonary valve in 4.2%, and movement of the implant in 4.2%.

The Harmony TPV device is contraindicated for patients with an infection in the heart or elsewhere, for patients who cannot tolerate blood thinning medicines, and for those with a sensitivity to nitinol (titanium or nickel).

Source: FDA

Clinic Hours In 1 min, Article

A new genetic mutation in schizophrenia discovered

The discovery of this new gene, PCDHA3, could enhance the development of genetic-risk calculators “that may help us understand vulnerability to schizophrenia in high-risk individuals and identify individuals with schizophrenia who have a greater risk for poor outcomes,” said Todd Lencz, PhD, a professor at the Feinstein Institutes for Medical Research in New York, and lead author of this research. It blocks neuron communication in the brain may lead to novel treatment strategies and improve understanding of the mechanics of this disease.

Source: Medscape

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FDA warns abuse of OTC decongestant potentially deadly

Abuse or misuse of the over-the-counter nasal decongestant propylhexedrine can cause serious harm that can lead to hospitalization, disability, or death, the US Food and Drug Administration (FDA) warns in a safety communication.

“Major issues” that may have to be managed in the context of acute intoxication with propylhexedrine include severe agitation, tachycardia, hypertension, myocardial infarction, hyperthermia, stroke, bowel obstruction, pulmonary hypertension, and seizures, the FDA said.

There is no specific agent for reversing the effects of acute propylhexedrine intoxication, so management is symptomatic and supportive, the FDA notes.

Source: FDA

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A 6 month multidrug regimen for MDR-TB trial is successful

The trial, called TB PRACTECAL, compared the current local standard of care with a six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. The interim analysis included 242 patients and the randomized controlled trial was conducted in sites in Belarus, South Africa, and Uzbekistan. The trial would support the first solely oral regimen for MDR-TB.

Médecins Sans Frontières (MSF/Doctors Without Borders) announced early closure of its phase 2/3 trial of a 6-month multidrug regimen for multidrug-resistant tuberculosis (MDR-TB) because an independent data safety and monitoring board.

Current treatment for MDR-TB lasts from 9 to 20 months. Side effects can include psychiatric problems from quinolones, isoniazid (INH), ethambutol, or cycloserine; deafness from aminoglycosides; and bone marrow suppression from linezolid, among other toxicities.

It’s hoped that the shorter regimen will reduce toxicity and improve patient compliance. Poor adherence to treatment is a major driver of further drug resistance. Current regimens require up to 20 pills per day as well as daily injections.

The 6-month BPaL regimen (bedaquiline, pretomanid, and linezolid) regimen works well in XDR-TB. The TB PRACTECAL regimen with one added drug (moxifloxacin) to work well in MDR-TB, which is less severe than XDR-TB.

Source: Medscape

Clinic Hours In Article, New Drug

FDA approves new ready to inject glucagon product

The US FDA has approved dasiglucagon (Zegalogue 0.6 mg/0.6 mL, Zealand Pharma) autoinjector and prefilled syringe for the treatment of severe hypoglycemia in people with diabetes aged 6 and older.

The product has a shelf-life of 36 months at refrigerated temperatures and is stable for up to 12 months at room temperature.

Dasiglucagon is currently in phase 3 trials as a SC infusion for treating congenital hyperinsulinemia, and in phase 2 trials as part of a bihormonal artificial pancreas pump system.

The FDA approval was based on results from three randomized, double-blind, placebo-controlled phase 3 studies of dasiglucagon in children age 6 to 17 years and adults with type 1 diabetes.

The primary endpoint was time to achieving an increase in blood glucose of 20 mg/dL or greater from time of administration without additional intervention within 45 minutes. That endpoint was achieved in all three studies, with a median time to blood glucose recovery of 10 minutes overall, with 99% of adults recovering within 15 minutes.

The most common adverse events reported in 2% or more of study participants were nausea, vomiting, headache, and injection site pain in both children and adults. Diarrhea was also reported in adults.

Full launch is expected in late June 2021.

Source: FDA

Clinic Hours In Article, COVID-19

Double mutant variant of the coronavirus has been detected in India

A new “double mutant” variant of the coronavirus has been detected from samples collected in India. Officials are checking if the variant, where two mutations come together in the same virus, may be more infectious or less affected by vaccines.

Some 10,787 samples from 18 Indian states also showed up 771 cases of known variants – 736 of the UK, 34 of the South African and one Brazilian.

The government said that an analysis of the samples collected from India’s western Maharashtra state showed “an increase in the fraction of samples with the E484Q and L452R mutations” compared with December last year. “Such double mutations confer immune escape and increased infectivity,” the health ministry said in a statement.

Source: BBC

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Menopausal hormone therapy curbs nocturia by improving sleep

Hormone therapy as a possible solution for postmenopausal women with nocturia.

A significant reduction in prevalence of nocturia ≥ twice per night was seen after treatment, as the prevalence decreased from 27.7% (59/213) to 16.4% (35/213). Specified per therapy, a significant reduction in nocturnal voiding frequency was observed in patients treated with E+P and TSEC (P = 0.018 and P = 0.018, respectively). This improvement could be explained by a significant reduction in SLEEP sum score in patients treated with E+P and TSEC (P < 0.001, P = 0.013, respectively). Estrogen-only led to a significant change in URINARY TRACT sum score, which is the result of a reduction in urgency prevalence (P = 0.039).

Estrogen + Progesterone (E+P), tissue-selective estrogen complex (TSEC) treatment led to a significant reduction in nocturia prevalence and bother in women with ≥ 2 nocturnal voids.

Source: Menopause Journal

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IDSA updates COVID-19 treatment guidelines

The Infectious Diseases Society of America (IDSA) continues to examine available and potential treatments as new evidence emerges.

Combination use of the monoclonal antibodies bamlanivimab and etesevimab to treat outpatients with mild-to-moderate disease at risk of progressing to severe COVID-19, for example, is a new recommendation in IDSA guidelines.

The society also updated its guidance on use of tocilizumab, pointed to less evidence on bamlanivimab monotherapy, and recommended against use of ivermectin outside of clinical trials.

Source: IDSA