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FDA approves a new drug for multi-drug resistant HIV-1

Lenacapavir is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1. The drug blocks the HIV-1 virus protein shell and interferes with essential steps of the virus evolution. Lenacapavir is administered only twice annually, but it is also combined with other antiretrovirals. After the initial doses are completed — given both orally and via subcutaneous injection — the drug is administered by injection every 6 months. The injections and oral tablets of lenacapavir are estimated to cost $42,250 in the first year of treatment and then $39,000 annually in the subsequent years.

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Adagrasib approved for KRAS-Mutated NSCLC

The US FDA has approved Adagrasib (Krazati) for use in adults with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer (NSCLC) that has progressed on at least one prior systemic therapy.

Dose: 600mg BD

Adverse reactions: Diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation.

Laboratory abnormalities: Decreased lymphocytes, increased aspartate aminotransferase, decreased sodium, decreased hemoglobin, increased creatinine, and decreased albumin.

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ADA advises new BP, lipid targets for people with diabetes

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes 2023. The new definition of hypertension in people with diabetes is ≥ 130 mmHg systolic or ≥ 80 mmHg diastolic blood pressure, repeated on two measurements at different times. Among individuals with established cardiovascular disease, hypertension can be diagnosed with one measurement of ≥ 180/110 mmHg. The goal of treatment is now less than 130/80 mmHg if it can be reached safely.

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Potential new biomarker for early stage Alzheimer disease

Investigators found that levels of formic acid, a metabolic product of formaldehyde found in urine, were significantly higher in individuals with Alzheimer disease including those with subjective cognitive decline, which may indicate very early stages of the disorder. Urinary formic acid and formaldehyde are likely to be new biomarkers independent of the existing AD diagnostic criteria. Researchers also compared formic acid and formaldehyde levels across different AD stages and found significantly higher levels across all stages compared with people who had no cognitive decline. Levels were also higher in patients with AD than in patients with MCI and those with cognitive impairment and no MCI, as well as in those with poorer neurologic test scores.

Source: Frontiers

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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.

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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.

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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.

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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.

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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.

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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.