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FDA approves Efgartigimod for Myasthenia Gravis

The US FDA has approved efgartigimod (Brand name: Vygart) a first-in-class, targeted therapy for adults with generalized myasthenia gravis (gMG) who test positive for the antiacetylcholine receptor (AChR) antibody.

Efgartigimod is an antibody fragment designed to reduce pathogenic IgG antibodies and block the IgG recycling process in patients with gMG. The novel agent binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels.

The most common side effects associated with the use of Vyvgart include respiratory tract infections, headache, and urinary tract infections. As Vyvgart causes a reduction in IgG levels, the risk of infections may increase. Hypersensitivity reactions such as eyelid swelling, shortness of breath, and rash have occurred. If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy.

Source: FDA

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Abrocitinib approved for Atopic Dermatitis in Europe

The oral Janus kinase 1 inhibitor abrocitinib has been approved in Europe for the treatment of moderate to severe atopic dermatitis (AD) in adults, who are candidates for systemic therapy. Approval by the European Commission was based on the results of studies that include four phase 3 clinical trials (JADE MONO-1, JADE-MONO-2, JADE COMPARE, JADE REGIMEN) and an ongoing open-label extension study (JADE EXTEND) in over 2,800 patients.

Source: Mdedge

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FDA approves PreHevbrio: The first 3-antigen HBV vaccine for adults

PreHevbrio [Hepatitis B Vaccine (Recombinant)]: contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.A.

INDICATIONS AND USAGE: PREHEVBRIO is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PREHEVBRIO is approved for use in adults 18 years of age and older.

DOSAGE AND ADMINISTRATION :For intramuscular injection. Administer a series of three doses (1.0 mL each) of PREHEVBRIO on a 0-, 1 and 6-month schedule.

CONTRAINDICATIONS: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PREHEVBRIO.

ADVERSE REACTIONS: Injection site pain, tenderness, headache (most common), fatigue and myalgia.

Source: FDA

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New AKI risk score for PCI patients passes validation

A pair of updated scoring models for estimating a patient’s risk for contrast-associated acute kidney injury during and immediately after percutaneous coronary intervention (PCI) worked better than a widely used prior version in initial validation testing using data collected at a single US tertiary-care hospital. One of the two new algorithms, which both predict a patient’s risk for developing acute kidney injury (AKI) as a result of receiving iodinated contrast media within 48 hours of a PCI, relies on eight easily available variables taken from a patient’s medical record just prior to undergoing PCI: age, type of coronary disease (ranging from asymptomatic or stable angina to ST-segment elevation MI), estimated glomerular filtration rate, left ventricular ejection fraction, diabetes, hemoglobin, basal glucose, and heart failure. This risk score accounted for 72% (a C-statistic of 0.72) of the observed AKI episodes during the derivation phase, which used data from 14,616 consecutive Mount Sinai patients who underwent PCI during January 2012–December 2017.

Source: Medscape

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FDA expands Pembrolizumab approval for Advanced Melanoma

The US Food and Drug Administration has approved pembrolizumab (Keytruda) for the adjuvant treatment of stage IIB and IIC melanoma after complete resection in adults and children over age 12 years. The FDA also extended the approval to those with stage III disease. The FDA approval on December 3 was based on the first interim findings from the randomized, placebo-controlled KEYNOTE-716 trial, which evaluated patients with stage IIB and IIC disease.

Source: Medscape

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Definitions for SARS-CoV-2 Variant of Interest & Variant of Concern

WHO has working definitions for SARS-CoV-2 Variant of Interest (VOI) and Variant of Concern (VOC).

A SARS-CoV-2 VOI is a SARS-CoV-2 variant with genetic changes that are predicted or known to affect virus characteristics such as transmissibility, disease severity, immune escape, diagnostic or therapeutic escape; and that has been identified as causing significant community transmission or multiple COVID-19 clusters, in multiple countries with increasing relative prevalence alongside increasing number of cases over time, or other apparent epidemiological impacts to suggest an emerging risk to global public health.

A SARS-CoV-2 VOC is a SARS-CoV-2 variant that meets the definition of a VOI (see above) and, through a comparative assessment, has been demonstrated to be associated with one or more of the following changes at a degree of global public health significance, increase in transmissibility or detrimental change in COVID-19 epidemiology; OR increase in virulence or change in clinical disease presentation; OR decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics.

Source: WHO

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Omicron: A variant of concern

WHO designated the variant B.1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). It is not yet clear whether Omicron is more transmissible compared to other variants, including Delta. The number of people testing positive has risen in areas of South Africa affected by this variant, but epidemiologic studies are underway. It is not yet clear whether infection with Omicron causes more severe disease compared to infections with other variants, including Delta. Preliminary data suggests that there are increasing rates of hospitalization in South Africa, but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection with Omicron. there may be an increased risk of reinfection with Omicron as compared to other variants of concern, but information is limited. The widely used PCR tests continue to detect infection, including infection with Omicron, as we have seen with other variants as well.

Source: WHO

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The case of the ‘Esperanza patient’ whose HIV infection vanished naturally

Researchers have reported that a woman living with HIV in Argentina is now the second person whose immune system rid itself of the virus. She was diagnosed with HIV-1 in 2013. Researchers found that she might potentially be an “elite controller” of the virus, showing no signs of active HIV infection in the 8 years since her diagnosis.

The Esperanza patient is just the second person reported to have possibly staved off the virus naturally- ultimately erasing any signs of active HIV without the assistance of medical therapies like stem cell transplants. The first was a woman from California, Loreen Willenberg, who is now 67 years old. She was diagnosed with HIV in 1992, and her immune system apparently performed the same function of naturally eliminating HIV.

Source: Healthline

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FDA approves Vosoritide for children with Achondroplasia

The US FDA has approved vosoritide (Voxzogo) daily injection for the treatment of children with achondroplasia. Indicated to increase linear growth in pediatric patients aged ≥5 years who have achondroplasia with open epiphyses.

Route: SC Inj.

MOA: Analog of C-type natriuretic peptide (CNP); this peptide binds to natriuretic-peptide receptor B (NPR B), which induces synthesis of cGMP molecules, which, in turn, inhibits the MAPK pathway.

Adverse Effects: Injection site erythema (75%), Injection site swelling (62%), Vomiting (27%), Injection site urticaria (25%), Arthralgia (15%), Decreased blood pressure (13%), Gastroenteritis (13%)

Source: Medscape

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FDA approves ropeginterferon for adults with polycythemia vera

The U.S. FDA approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots.

Besremi has a longer half-life than do other pegylated interferon-alfas, allowing for dosing every 2 weeks instead of weekly.

Besremi can cause liver enzyme elevations, low levels of white blood cells, low levels of platelets, joint pain, fatigue, itching, upper airway infection, muscle pain and flu-like illness. Side effects may also include urinary tract infection, depression and transient ischemic attacks. May cause or worsen neuropsychiatric, autoimmune, ischemic and infectious diseases.

Source: FDA