FDA has issued an emergency use authorization (EUA) for the use of Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support).
The treatment targets a part of the immune system that is thought to play a role in the inflammation that leads to COVID-19 disease progression. The clinical trial supporting the authorization showed that patients treated with Gohibic had a lower risk of death by day 28 and day 60 of treatment compared to placebo.
“COVID-19 treatments remain a priority for CDER, as the disease continues to impact the lives of Americans,” said Center Director Patrizia Cavazzoni, M.D. “Today's authorization offers another potentially life-saving treatment option for the sickest COVID-19 patients.”
The recommended dosage of Gohibic is 800 mg administered by intravenous infusion after dilution, given up to six times over the treatment period. The most common adverse reactions with use of Gohibic are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash. Serious infections due to bacterial, fungal, or viral pathogens have been reported in patients with COVID-19 receiving Gohibic.
Additional safety information, dosing instructions, and potential side effects can be found in the authorized Fact Sheet for Health Care Providers. Additional information on authorized COVID-19 treatments is available on FDA’s Emergency Use Authorization webpage.
The FAI climbed 5.9 percent year-on-year in the first 11 months of 2018, quickening from the 5.7-percent growth in Jan-Oct, the National Bureau of Statistics (NBS) said Friday in an online statement.
The key indicator of investment, dubbed a major growth driver, hit the bottom in August and has since started to rebound steadily.
In the face of emerging economic challenges home and abroad, China has stepped up efforts to stabilize investment, in particular rolling out measures to motivate private investors and channel funds into infrastructure.
Friday's data showed private investment, accounting for more than 60 percent of the total FAI, expanded by a brisk 8.7 percent.
NBS spokesperson Mao Shengyong said funds into weak economic links registered rapid increases as investment in environmental protection and agriculture jumped 42 percent and 12.5 percent respectively, much faster than the average.
In breakdown, investment in high-tech and equipment manufacturing remained vigorous with 16.1-percent and 11.6-percent increases respectively in the first 11 months. Infrastructure investment gained 3.7 percent, staying flat. Investment in property development rose 9.7 percent, also unchanged.