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FDA approves first drug to delay type 1 diabetes onset

The US FDA has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition. It is administered by intravenous infusion once daily for 14 consecutive days. The specific indication is to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Type 1 diabetes staging:

  • Stage 1: Presence of beta-cell autoimmunity with two or more islet autoantibodies with normoglycemia
  • Stage 2: Beta-cell autoimmunity with dysglycemia yet asymptomatic
  • Stage 3: Symptomatic onset of type 1 diabetes.

Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

Clinical Inshorts by ClinicHours

FDA approves new Immunotherapy combination for mNSCLC

The US FDA has approved a new combination of immunotherapies for use together with platinum-based chemotherapy for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) whose tumors do not have EGFR mutations or ALK aberrations. The new combination comprises two drugs that act at different immune checkpoints: the CTLA-4 inhibitor tremelimumab (Imudo) and the anti-PDL1 antibody durvalumab (Imfinzi). This combination was recently approved for the first time for use in liver cancer, and durvalumab is already approved for use in lung cancer, bladder cancer, and biliary tract cancers.

Inshorts by ClinicHours

GFAP & NfL may be complementary biomarkers for MS

Neurofilament light chain (NfL) is a biomarker for both disease progression and treatment response in multiple sclerosis (MS), but the search continues for additional biomarkers to distinguish between disease activity and progression. Serum glial fibrillary acid protein (GFAP) could be a useful complement to NfL in MS, although it is not ready for the clinic.NfL is a structural protein of neurons, while GFAP is a structure protein of astrocytes. NfL therefore reflects neuronal damage, while GFAP is an indicator of astrogliosis and astrocytic damage. GFAP has been shown to be increased in progressive MS and has been applied in traumatic brain injury and neuromyelitis optica spectrum disorder. Serum GFAP is a promising biomarker reflecting progression in MS and it is complementary to NfL.

Inshorts by ClinicHours

Vonoprazan is superior to PPI for erosive esophagitis

The oral potassium-competitive acid blocker vonoprazan was superior to the proton pump inhibitor lansoprazole for erosive esophagitis, according to results of the phase 3 PHALCON-EE trial. The 878 patients with healing were re-randomized to receive vonoprazan 10 mg 1 OD, vonoprazan 20 mg, or lansoprazole 15 mg for 24 weeks in the maintenance phase. For maintenance of healing at week 24, vonoprazan was noninferior to lansoprazole in the primary analysis and superior on secondary analysis of healing (80.7% for vonoprazan 20 mg and 79.2% for vonoprazan 10 mg vs 72.0% for lansoprazole; P < .0001 for both comparisons). As expected, serum gastrin increased to a greater extent with vonoprazan than lansoprazole, with levels > 500 pg/mL in 16% of those taking 20 mg at the end of maintenance therapy, the authors report. After stopping vonoprazan, gastrin levels dropped by roughly 60%-65% within 4 weeks. Last May, the FDA approved two vonoprazan based therapies for the treatment of H pylori infection.

Inshorts by ClinicHours

FDA approves SC furosemide preparation

The US FDA has approved a furosemide preparation (Furoscix, scPharmaceuticals) intended for subcutaneous self-administration by outpatients with CHF and volume overload. The product is used with a SmartDose On-Body Infuser (West Pharmaceutical Services) single-use SC administration device, which affixes to the abdomen. The infuser is loaded with a prefilled cartridge and is programmed to deliver Furosemide 30 mg over 1 hour followed by a 4-hour infusion at 12.5 mg/h, for a total fixed dose of 80 mg.

Inshorts by ClinicHours

FDA approves Ibalizumab for HIV-1 treatment

Ibalizumab is a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug resistant HIV-1. It is used in combination with other antiretroviral drugs. Prior to this approval, the drug was administered intravenously as a single 2000 mg loading dose, followed by an 800 mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15 to 30 minutes. Now, the maintenance dose can be administered by IV push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds. Adverse effects of ibalizumab include diarrhea, dizziness, nausea, rash, immune reconstitution inflammatory syndrome.

Inshorts by ClinicHours

FDA approves Dupilumab for treatment of Prurigo Nodularis

The US FDA has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication.

MOA: Dupilumab (Dupixent), which inhibits the signaling of the interleukin 4 and interleukin 13 pathways, show significant improvements in both itchiness and lesion counts compared with placebo in adults with prurigo nodularis (PN).

 Dose: 300 mg SC injection every 2 weeks after a loading dose.

Adverse effects: nasopharyngitis, conjunctivitis, herpes infection, muscle pain, diarrhea

Inshorts by Clinichours

Tezepelumab approved for severe uncontrolled asthma

Tezepelumab is an epithelial cytokine, and is the first and only biologic approved in Europe by EC for severe asthma for adults and adolescents with inadequately controlled severe asthma with no phenotype or biomarker limitations. Tezepelumab acts by blocking thymic stromal lymphopoietin (TSLP). Most common adverse events in patients were pharyngitis, rash, arthralgia, and injection site reactions.

Inshorts by Clinichours

(CAR) T-cell therapy treats SLE successfully

The five patients all of whom had an aggressive form of SLE underwent a single infusion of the experimental treatment. All five patients were able to stop their standard treatments for as long as 17 months following the therapy, the study found. The patients also stopped experiencing severe symptoms such as lung inflammation, fibrosis of the heart valves, arthritis, and fatigue. The patients have not relapsed. All of the patients were treated with genetically engineered T cells known as chimeric antigen receptor (CAR) T-cell therapy, a treatment regularly used to kill cancer cells. Researchers harvested the patients’ immune cells and engineered them to destroy dysfunctional cells when infused back into the body.

Use of Nirsevimab against respiratory syncytial virus (RSV) in Infants

RSV is the leading cause of lower respiratory tract infections in infants. Worldwide, acute lower respiratory infections associated with RSV account for about 1.4 million hospitalizations & 27,300 in-hospital deaths among infants under the age of 6 months annually, according to the WHO. Nirsevimab is a long-acting antibody given as a single intramuscular injection at a dose of 50 mg for infants with a body weight of less than 5 kg, and 100 mg for infants weighing at least 5 kg. If approved, nirsevimab will be the only preventative option for the broad newborn and infant population against RSV.

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