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FDA approves Evinacumab-dgnb for Homozygous familial hypercholesterolemia

The US FDA has approved the fully human monoclonal antibody evinacumab-dgnb (Evkeeza, Regeneron Pharmaceuticals) for use on top of other cholesterol-modifying meds in patients aged 12 and older with homozygous familial hypercholesterolemia (HoFH).

Mechanism: Evinacumab-dgnb is a fully-human monoclonal antibody that binds to and blocks the function of ANGPTL3.

Dose: 15 mg/kg) once a month via intravenous infusion.

Adverse Effects: Nasopharyngitis, influenza-like illness, dizziness, rhinorrhea, nausea, pain in extremity and asthenia.

Cost: $450,000 per year

Extra notes: Reductions in LDL-C seen were observed as early as week 2 and maintained throughout the double-blind treatment period (week 24) and open-label trial period (through week 48).

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Pembrolizumab ‘Preferred Choice’ in MSI-H/dMMR Metastatic CRC

Pembrolizumab significantly improved progression-free survival compared with chemotherapy among patients with microsatellite instability–high/mismatch repair–deficient (MSI-H/dMMR) metastatic colorectal cancer, according to results from the KEYNOTE-177 study.

Study Details: The KEYNOTE-177 trial included 307 patients with confirmed, untreated MSI-H/dMMR metastatic colorectal cancer who were randomly assigned to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles (n = 153) or the investigators’ choice of chemotherapy (n = 154). Chemotherapy regimens included modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab. Patients in the chemotherapy group could cross over to pembrolizumab therapy after disease progression.

Source: Medscape

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Ruxolitinib as second line drug in Chronic GVHD

Ruxolitinib, a JAK inhibitor first marketed for use in myelofibrosis, is already approved for acute GVHD. The US Food and Drug Administration approved that indication last year on the basis of data from two previous trials, REACH 1 and REACH 2. The trials found that ruxolitinib was superior to best available therapy for treating patients with acute GVHD.

In the current REACH 3 study, Zeiser and colleagues compared ruxolitinib with best available therapy in 329 patients with moderate-to-severe cGVHD (both steroid dependent and steroid resistant).

Source: Medscape

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Human to human transmission of Chapare virus in Bolivia

Chapare hemorrhagic fever (CHHF) is a viral hemorrhagic fever caused by infection with Chapare virus. The Chapare virus is in the arenavirus family. Arenaviruses are usually spread to people through direct contact with infected rodents or indirectly through the urine or feces (droppings) of an infected rodent.

There have been two documented outbreaks of CHHF to date. The first occurred in 2003 in Chapare Province, Bolivia, which resulted in one fatal case. The second outbreak occurred in 2019 in Caranavi Province, Bolivia and resulted in five confirmed cases— three of which were fatal.

Transmission: Rodent reservoir of Chapare virus is unknown, similar arenaviruses are typically transmitted either through direct or indirect contact with the saliva, urine, and droppings of infected rodents.

Signs & Symptoms: The documented signs and symptoms of CHHF from the first and second outbreaks included some or all of the following:

fever
headache
joint and muscle pain
pain behind the eyes
stomach pain
vomiting
diarrhea
bleeding gums
rash
irritability

Diagnosis: real-time reverse transcription polymerase chain reaction (rRT-PCR). CDC advises a Biosafety Level 4 laboratory, strictly following all protocols for personal protection, sample inactivation and waste disposal.

Treatment: There is currently no treatment for CHHF. Supportive therapy is important for recovery from and survival of CHHF. This includes:

maintenance of hydration,
management of shock (eg, fluid resuscitation, administration of vasopressin stocks)
sedation
pain relief
transfusions (when necessary)

Source: CDC

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VEXAS Syndrome

Researchers from the National Institutes of Health (NIH) have discovered a new inflammatory disorder called Vacuoles, E1 enzyme, X-linked, Autoinflammatory and somatic Syndrome (VEXAS), which is caused by mutations in the UBA1 gene.

VEXAS causes symptoms that included blood clots in veins, recurrent fevers, pulmonary abnormalities and vacuoles (unusual cavity-like structures) in myeloid cells.

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Protein predicts risk of AKI in COVID-19 patients

Levels of a specific protein Soluble urokinase plasminogen activator receptor (suPAR) produced by immune cells predicts a very high risk of AKI. Median suPAR level 60% higher in patients with vs without AKI.

The current analysis involved 352 patients with COVID-19 who had a mean estimated glomerular filtration rate (eGFR) of 80 mL/min/1.73m2 at admission.

suPAR was measured in plasma using a commercially available ELISA (suPARnostic assay by ViroGates).

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Endoscopic Sleeve Gastroplasty safe, Effective for obesity over 5 years

Endoscopic sleeve gastroplasty (ESG) was safe and effective for weight loss, during a single-centre five-year follow-up study.

“It is a great procedure, patients are satisfied, and it achieves good results,” Dr. Reem Sharaiha of Weill Cornell Medicine in New York City told Reuters Health by email. “ESG has been gaining momentum among the patient population. Many were interested in the long-term results of endoscopic approaches, including insurances/bariatric surgeons, as most (studies) have not shown durability in the past.”

Dr Sharaiha and colleagues studied 216 patients who underwent ESG at Weill Cornell from 2013-2019 (mean age, 46; 68% women). During the procedure, the endoscopist inserts a suturing device through the mouth and into the stomach, which is sutured to make it smaller.

Study participants had a body mass index of >30 kg/m2 (or >27 with comorbidities) and had failed to achieve a total body weight loss (TBWL) of at least 5% with noninvasive measures such as drugs.

Source: Medscape

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FDA approves Somapacitan-beco for Adult Growth Hormone Deficiency treatment

FDA approves Sogroya (somapacitan-beco) a 0nce-weekly treatment for Adult Growth Hormone Deficiency.

Sogroya (somapacitan-beco) injection 10 mg/1.5 mL (6.7 mg/mL) is a human growth hormone analog taken once a week by subcutaneous injection. The FDA’s decision is based on a comprehensive clinical program, including the REAL 1 study, a 35-week, double-blind, placebo-controlled study, in treatment-naïve adult patients with GHD.

Sogroya may cause serious side effects, including:

High risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing problems
Increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer
New or worsening high blood sugar or diabetes
Odema
Decrease in a hormone called cortisol
Decrease in thyroid hormone levels.
Severe and constant abdominal pain. This could be a sign of pancreatitis
Loss of fat and tissue weakness in the area of skin you inject.
Increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood

The most common side effects of Sogroya may include back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils, vomiting, high blood pressure, increase creatine phosphokinase, weight gain, and low red blood cells

Source: FDA

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Antihypertensive drugs that reduces risk for Depression

The risk of depression is elevated in patients with cardiovascular diseases, but several specific antihypertensive therapies are associated with reduced risk, and none appear to increase the risk, according to a population-based study that evaluated 10 years of data in nearly 4 million subjects.

Agents associated with a reduced risk of depression were: two angiotensin agents, enalapril and ramipril; three calcium antagonists, amlodipine, verapamil, and verapamil combinations; and four beta-blockers, propranolol, atenolol, bisoprolol, and carvedilol.

Source: Medscape

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FDA approves saliva test to detect COVID-19

FDA approves emergency use of Saliva Test to detect COVID-19

Rutgers University-based RUCDR Infinite Biologics developed a saliva collection method in partnership with Spectrum Solutions and Accurate Diagnostic Labs.

The document states that the collection of saliva specimens is limited to patients with symptoms of COVID-19 and should be performed in a health care setting under the supervision of a trained health care clinician. Samples are transported for RNA extraction and are tested within 48 hours of collection. In saliva samples obtained from 60 patients evaluated by the researchers, all were in agreement with the presence of COVID-19.

Source: Medscape