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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

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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

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Interesting case of Ocular vicarious menstruation in India

A 25-year-old married woman recently went to the emergency room at a hospital in Chandigarh, India after she experienced haemolacria (crying tears of blood). Interestingly, she wasn’t in any pain or discomfort and told doctors that she experienced the same thing a month as well.

She even underwent a vast array of tests to ascertain the root cause of her bleeding eyes, but all reports came normal. Neither were there any injuries to the eyes, nor she didn’t have a family history of an ocular bleeding condition or any past issues with her eyes. So, what was really causing it?

Vicarious menstruation represents cyclical bleeding in extragenital organs during a normal menstrual cycle. The ocular surface is confirmed to be an estrogen-dependent unit.

Though the exact anatomical cause is still relatively unknown, experts believe endometriosis or the presence of endometrial tissue in extragenital organs can be a factor in developing vicarious menstruation.

“Oestrogen and progesterone can increase the permeability of capillaries resulting in hyperaemia, congestion and secondary bleeding from extrauterine tissue,” the study’s authors said. The woman was treated with oral contraceptives containing a combination of estrogen and progesterone. She told the doctors that she didn’t experience bloody tears after a three-month follow-up.

Cases of haemolacria have been attributed to a number of causes and conditions. Some of the more common include hormone changes, menstruation, inflammation, conjunctival injuries, trauma, blocked tear duct, high blood pressure, blood disorders, such as hemophilia, nosebleeds, pyogenic granuloma, melanoma and tumors.

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Ertugliflozin, the (SGLT2) inhibitor has renal benefits also

Ertugliflozin, the sodium-glucose cotransporter 2 (SGLT2) inhibitor class, now has shown evidence of renal benefits roughly on par with the other three drugs.

Treatment of patients with type 2 diabetes and established atherosclerotic cardiovascular disease (CVD) with ertugiflozin (Steglatro) led to significant reductions in the incidence of four prespecified, exploratory kidney endpoints in the VERTIS CV trial, which included more than 8200 patients.

Most notable of the new exploratory analyses is a composite of time to a sustained 40% reduction from baseline in estimated glomerular filtration rate (eGFR) or time to renal dialysis, transplant, or death, the incidence for which was a significant 34% lower with ertugliflozin treatment.

Source: Medscape

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Omidubicel improves on umbilical cord blood transplants

Omidubicel, an investigational enriched umbilical cord blood product being developed by Gamida Cell for transplantation in patients with blood cancers, appears to have some advantages over standard umbilical cord blood.

The results come from a global phase 3 trial presented at the annual meeting of the European Society for Blood and Bone Marrow Transplantation.

“Transplantation with omidubicel compared to standard cord blood transplantation results in faster hematopoietic recovery, fewer infections, and fewer days in the hospital,” said coinvestigator Guillermo F. Sanz, MD, PhD, from the Hospital Universitari i Politècnic la Fe in Valencia, Spain.

“Omidubicel should be considered as the new standard of care for patients eligible for umbilical cord blood transplantation,” Sanz concluded. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.

Source: Medscape

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CDC & WHO establish new threat levels for COVID-19 variants

The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have established new criteria to classify variants of SARS-CoV-2, the virus that causes COVID-19.

The criteria are meant to clarify how much is known about recent changes to the circulating viruses. The levels also help convey risk.

The new designations are “variant of interest”; “variant of concern”; and “variant of high consequence.”

A variant of interest has caused discrete clusters of infections in the United States or in other countries or seems to be driving a surge in cases. It also has gene changes that suggest it might be more contagious or that may help it to escape immunity conferred by natural infection or vaccination. Therapeutics and tests may not work as well against it. The CDC is watching three of these.

A variant of concern has been proven through scientific research to be more contagious or to cause more severe disease. It may also reduce the effectiveness of therapeutics and vaccines. People who have previously had COVID-19 may become reinfected by the new strain. The CDC is tracking five of these.

A variant of high consequence causes more severe disease and greater numbers of hospitalizations. It has also been shown to defeat medical countermeasures, such as vaccines, antiviral drugs, and monoclonal antibodies. So far, none of the variants meets this definition.

Source: CDC.gov

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Roche is launching a SARS-CoV-2 variant test

Roche is launching a SARS-CoV-2 variant test to help monitor emerging coronavirus mutations. The test runs on widely used high-throughput systems and is for research purposes only. The new SARS-CoV-2 Variant Set 1 Test is designed to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1)

Source: Reuters

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Weight gain linked to HP Dysfunction in pediatric brain tumor survivors

Children who have been treated for brain tumors often experience significant weight gain, and new findings suggest that this could be a sign of hypothalamic-pituitary (HP) dysfunction.

The Dutch study of 661 children who survived a brain tumor found that one third become overweight, obese, or had gained a significant amount of weight during the follow-up period.

Among 578 survivors who were between 4 and 20 years of age at follow-up, 20.3% were classified as overweight and 8.5% as obese, as compared with 10.5% and 2.7%, respectively, in the general Dutch population within the same age group.

Source: The Journal of Clinical Oncology