Apretude (cabotegravir extended-release injectable suspension) for HIV Preexposure Prophylaxis (PrEP)

The Food and Drug Administration (FDA) approved Apretude for use in at-risk adults and adolescents weighing at least 35kg for PrEP to reduce the risk of sexually acquired HIV infection. Apretude contains an extended-release formulation of cabotegravir, an HIV integrase strand transfer inhibitor. The product is administered initially as a single intramuscular injection given 1 month apart for 2 consecutive months, then every 2 months thereafter. The approval was based on trial results that showed the injectable was significantly more effective at preventing HIV acquisition compared with oral emtricitabine/tenofovir disoproxil fumarate 200mg/300mg.

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Leqvio (inclisiran) for Heterozygous Familial Hypercholesterolemia (HeFH) or Clinical Atherosclerotic Cardiovascular Disease (ASCVD)

Leqvio is a chemically synthesized small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA. The product is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of HeFH or clinical ASCVD in adults who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Leqvio is administered as an initial single subcutaneous injection, with a second dose at 3 months, and continued treatment once every 6 months. Results from multiple trials showed that the treatment significantly reduced LDL-C compared with placebo.

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Tarpeyo (budesonide) to Reduce Proteinuria in Primary IgA Nephropathy

Accelerated approval was granted to Tarpeyo (budesonide) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) of at least 1.5g/g. Tarpeyo contains 4mg of budesonide in a delayed-release capsule. Results from a phase 3 trial showed that treatment with Tarpeyo was associated with a 34% reduction in UPCR at 9 months compared with a 5% reduction for placebo. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN.

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Tezspire (tezepelumab-ekko) as Add-On Maintenance Treatment for Severe Asthma

Tezspire is a first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine involved in the initiation and persistence of airway inflammation. It is approved as add-on maintenance treatment of patients 12 years of age and older with severe asthma and is the first treatment for this indication that is not limited to a specific phenotype or biomarker.  In the overall study population, Tezspire was associated with a statistically significant and clinically meaningful 56% reduction in annualized asthma exacerbation rate compared with placebo. The product is administered subcutaneously by a health care provider once every 4 weeks.

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Vyvgart (efgartigimod alfa-fcab) for Generalized Myasthenia Gravis

Vyvgart is a neonatal Fc receptor antagonist designed to reduce immunoglobulin G (IgG) antibody levels and block the IgG recycling process. It is approved for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. Findings from a phase 3 trial showed that a significantly greater proportion of AChR-Ab+ patients treated with Vyvgart met the primary end point (percentage of responders on the Myasthenia Gravis Activities of Daily Living score) compared with placebo. Vyvgart is administered via intravenous infusion following dilution.

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  1. Apretude. Package Insert. ViiV Healthcare; 2021. Accessed January 5, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF.
  2. Leqvio. Package Insert. Novartis Pharmaceuticals Corp; 2021. Accessed January 5, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214012lbl.pdf.
  3. Tarpeyo. Package Insert. Calliditas Therapeutics; 2021. Accessed January 5, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215935s000lbl.pdf.
  4. Tezspire. Package Insert. Amgen; 2021. Accessed January 5, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761224s000lbl.pdf.
  5. Vyvgart. Package Insert. argenx SE; 2021. Accessed January 5, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761195s000lbl.pdf.