ADVERTISEMENT

US grants emergency approval to Lilly Covid-19 antibodies

Published Nov 10, 2020 11:56 am

The US Food and Drug Administration on Monday granted emergency approval to a synthetic antibody treatment against Covid-19 developed by Eli Lilly, after the drug was shown to reduce the risk of hospitalization and emergency room visits.

An electron micrograph of SARS-CoV-2 virus particles, isolated from a patient, captured and color-enhanced at the NIAID Integrated Research Facility. (AFP / MANILA BULLETIN)
An electron micrograph of SARS-CoV-2 virus particles, isolated from a patient, captured and color-enhanced at the NIAID Integrated Research Facility. (AFP / MANILA BULLETIN)

Bamlanivimab at a dose of 700 milligrams was authorized for the treatment of mild-to-moderate Covid-19 in adults and children aged 12 years and older who are at high risk for progressing to the severe form of the disease.

It is the first major drug to be approved that was designed specifically against the new coronavirus.

"As illustrated by today's action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments," said the agency's chief Stephen Hahn.

The approval was based on a mid-stage clinical trial for outpatients with mild to moderate Covid-19, where the intravenous treatment was shown to reduce viral loads and rates of symptoms and hospitalization. 

The FDA said in its statement that the most important evidence that bamlanivimab may be effective came from data that showed that among patients at high risk of severe disease, hospitalizations and emergency room visits occurred in 3 percent of bamlanivimab-treated patients compared to 10 percent who were on the placebo.

The frequency and types of side effects were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. 

The most common were diarrhea, dizziness, headache, itchiness and vomiting.

The trial is ongoing and aims to enroll more than 800 patients across various dosage groups.

An important caveat is that bamlanivimab has not been authorized for patients who are hospitalized -- since no benefit has been shown for patients who are already in this late stage of the disease, when the body's immune defenses go into overdrive and damage organs.

The FDA wrote that administering the drug too late could be associated with worse outcomes, and a trial exploring bamlanivimab in hospitalized patients was suspended last month over a safety incident.

Bamlanivimab is what's known as a monoclonal antibody, a relatively new class of drugs that are best known for treating certain types of cancer and autoimmune disease.

Human immune systems produce antibodies, which are infection-fighting proteins, and vaccines teach our bodies to be prepared to make the right ones for particular pathogens.

Bamlanivimab was based on an effective antibody Lilly found in a recovered patient.

The host immune cells that produce the antibodies can be cultured in a lab to produce the desired proteins en masse.

It works by binding to a surface protein of the coronavirus to stop it from invading human cells.

Related Tags

ncov
ADVERTISEMENT
.most-popular .layout-ratio{ padding-bottom: 79.13%; } @media (min-width: 768px) and (max-width: 1024px) { .widget-title { font-size: 15px !important; } }

{{ articles_filter_1561_widget.title }}

.most-popular .layout-ratio{ padding-bottom: 79.13%; } @media (min-width: 768px) and (max-width: 1024px) { .widget-title { font-size: 15px !important; } }

{{ articles_filter_1562_widget.title }}

.most-popular .layout-ratio{ padding-bottom: 79.13%; } @media (min-width: 768px) and (max-width: 1024px) { .widget-title { font-size: 15px !important; } }

{{ articles_filter_1563_widget.title }}

{{ articles_filter_1564_widget.title }}

.mb-article-details { position: relative; } .mb-article-details .article-body-preview, .mb-article-details .article-body-summary{ font-size: 17px; line-height: 30px; font-family: "Libre Caslon Text", serif; color: #000; } .mb-article-details .article-body-preview iframe , .mb-article-details .article-body-summary iframe{ width: 100%; margin: auto; } .read-more-background { background: linear-gradient(180deg, color(display-p3 1.000 1.000 1.000 / 0) 13.75%, color(display-p3 1.000 1.000 1.000 / 0.8) 30.79%, color(display-p3 1.000 1.000 1.000) 72.5%); position: absolute; height: 200px; width: 100%; bottom: 0; display: flex; justify-content: center; align-items: center; padding: 0; } .read-more-background a{ color: #000; } .read-more-btn { padding: 17px 45px; font-family: Inter; font-weight: 700; font-size: 18px; line-height: 16px; text-align: center; vertical-align: middle; border: 1px solid black; background-color: white; } .hidden { display: none; }
function initializeAllSwipers() { // Get all hidden inputs with cms_article_id document.querySelectorAll('[id^="cms_article_id_"]').forEach(function (input) { const cmsArticleId = input.value; const articleSelector = '#article-' + cmsArticleId + ' .body_images'; const swiperElement = document.querySelector(articleSelector); if (swiperElement && !swiperElement.classList.contains('swiper-initialized')) { new Swiper(articleSelector, { loop: true, pagination: false, navigation: { nextEl: '#article-' + cmsArticleId + ' .swiper-button-next', prevEl: '#article-' + cmsArticleId + ' .swiper-button-prev', }, }); } }); } setTimeout(initializeAllSwipers, 3000); const intersectionObserver = new IntersectionObserver( (entries) => { entries.forEach((entry) => { if (entry.isIntersecting) { const newUrl = entry.target.getAttribute("data-url"); if (newUrl) { history.pushState(null, null, newUrl); let article = entry.target; // Extract metadata const author = article.querySelector('.author-section').textContent.replace('By', '').trim(); const section = article.querySelector('.section-info ').textContent.replace(' ', ' '); const title = article.querySelector('.article-title h1').textContent; // Parse URL for Chartbeat path format const parsedUrl = new URL(newUrl, window.location.origin); const cleanUrl = parsedUrl.host + parsedUrl.pathname; // Update Chartbeat configuration if (typeof window._sf_async_config !== 'undefined') { window._sf_async_config.path = cleanUrl; window._sf_async_config.sections = section; window._sf_async_config.authors = author; } // Track virtual page view with Chartbeat if (typeof pSUPERFLY !== 'undefined' && typeof pSUPERFLY.virtualPage === 'function') { try { pSUPERFLY.virtualPage({ path: cleanUrl, title: title, sections: section, authors: author }); } catch (error) { console.error('ping error', error); } } // Optional: Update document title if (title && title !== document.title) { document.title = title; } } } }); }, { threshold: 0.1 } ); function showArticleBody(button) { const article = button.closest("article"); const summary = article.querySelector(".article-body-summary"); const body = article.querySelector(".article-body-preview"); const readMoreSection = article.querySelector(".read-more-background"); // Hide summary and read-more section summary.style.display = "none"; readMoreSection.style.display = "none"; // Show the full article body body.classList.remove("hidden"); } document.addEventListener("DOMContentLoaded", () => { let loadCount = 0; // Track how many times articles are loaded const offset = [1, 2, 3, 4, 5, 6, 7, 8, 9, 10]; // Offset values const currentUrl = window.location.pathname.substring(1); let isLoading = false; // Prevent multiple calls if (!currentUrl) { console.log("Current URL is invalid."); return; } const sentinel = document.getElementById("load-more-sentinel"); if (!sentinel) { console.log("Sentinel element not found."); return; } function isSentinelVisible() { const rect = sentinel.getBoundingClientRect(); return ( rect.top < window.innerHeight && rect.bottom >= 0 ); } function onScroll() { if (isLoading) return; if (isSentinelVisible()) { if (loadCount >= offset.length) { console.log("Maximum load attempts reached."); window.removeEventListener("scroll", onScroll); return; } isLoading = true; const currentOffset = offset[loadCount]; window.loadMoreItems().then(() => { let article = document.querySelector('#widget_1690 > div:nth-last-of-type(2) article'); intersectionObserver.observe(article) loadCount++; }).catch(error => { console.error("Error loading more items:", error); }).finally(() => { isLoading = false; }); } } window.addEventListener("scroll", onScroll); });

Sign up by email to receive news.