Problems at Eli Lilly plant could jeopardize antibody drug approval

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    <p class=”mol-para-with-font”>Quality control problems at an Eli Lilly plant discovered last year by FDA investigators could make it even harder for the company to get emergency approval for its coronavirus antibody drug, a Reuters investigation found.  </p><p class=”mol-para-with-font”>US drug inspectors uncovered serious compliance issues at an Eli Lilly pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as ‘a cure’ for the disease, according to government documents and three sources familiar with the matter.</p><p class=”mol-para-with-font”>The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19.</p><p class=”mol-para-with-font”>Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, for free, while incorrectly referring to them as ‘cures.'</p><p class=”mol-para-with-font”>His promotion of the drugs has raised expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. </p><p class=”mol-para-with-font”>The president’s push is key to his efforts to convince voters he has an answer to the pandemic that has killed more than 215,000 Americans.</p><p class=”mol-para-with-font”>But compliance issues at the manufacturing facility could undermine those efforts by calling the company’s fitness to safely produce the drug into question, sources within the agency and outside legal experts told Reuters.  </p><div class=”artSplitter mol-img-group” style=”style”> <div class=”mol-img”> <div class=”image-wrap”> Last year, FDA inspectors found compliance issues at an Eli Lilly plant manufacturing the coronavirus antibody drug the firm is seeking approval for. The regulatory red flags could jeopardize its chances of emergency authorization from the FDA (file) </div> <noscript> Last year, FDA inspectors found compliance issues at an Eli Lilly plant manufacturing the coronavirus antibody drug the firm is seeking approval for. The regulatory red flags could jeopardize its chances of emergency authorization from the FDA (file) </noscript> </div> <p class=”imageCaption”>Last year, FDA inspectors found compliance issues at an Eli Lilly plant manufacturing the coronavirus antibody drug the firm is seeking approval for.

    The regulatory red flags could jeopardize its chances of emergency authorization from the FDA (file) </p></div><p class=”mol-para-with-font”>The findings have not been disclosed previously. </p><p class=”mol-para-with-font”>That’s because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.</p><p class=”mol-para-with-font”>The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation.</p><p class=”mol-para-with-font”>Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.</p><p class=”mol-para-with-font”>’The deleted incidents and related audit trail were not reviewed by the quality unit,’ the FDA inspectors wrote. </p><p class=”mol-para-with-font”>Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.</p><p class=”mol-para-with-font”>Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an ‘Official Action Indicated’ (OAI) notice.</p><div><div data-track-module=”am-related_carousel^related_carousel” data-track-selector=”.rotator-panels a:not([class*=external])” data-dm-rotator-rotate=”false” data-track-pos=”static” data-preferred-shared-network-enabled=”” data-dm-rotator-auto-init=”” id=”p-20″ class=”related-carousel with-fb-or-tw health half” data-dm-rotator-active-class=”active” data-dm-rotator-page-count=”1.0″ data-dm-social-article-auto-init=”” data-dm-rotator-page-size=”1″> <div class=”rotator bdrcc”> <div class=”rotator-title”> <h2>RELATED ARTICLES</h2> <ul class=”rotator-pages link-xocc”> <li class=”rotator-prev”>Previous

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    </div> </div><p class=”mol-para-with-font”>That ‘means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,’ said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.</p><p class=”mol-para-with-font”>Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients ‘out of an abundance of caution’ over a potential safety concern. </p><p class=”mol-para-with-font”>The company did not release information on what the problem was and declined to say how the news might affect their EUA request.</p><p class=”mol-para-with-font”>In response to Reuters’ questions on Monday about the manufacturing issues, Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action. </p><p class=”mol-para-with-font”>The drugmaker said it has launched a ‘comprehensive remediation plan,’ has increased staffing at the site and was working ‘aggressively’ to address all concerns raised during the inspection.</p><p class=”mol-para-with-font”>The data deletions cited by the FDA, Lilly said, were not related to production of the drug.</p><div class=”artSplitter mol-img-group” style=”style”> <div class=”mol-img”> <div class=”image-wrap”> Lilly has developed two antibody treatments for coronavirus and has applied to the FDA for emergency approval of one of them. At least one is being manufactured at the New Jersey plant where FDA inspectors found oversight and drug control issues in November and August </div> <noscript> Lilly has developed two antibody treatments for coronavirus and has applied to the FDA for emergency approval of one of them. At least one is being manufactured at the New Jersey plant where FDA inspectors found oversight and drug control issues in November and August </noscript> </div> <p class=”imageCaption”>Lilly has developed two antibody treatments for coronavirus and has applied to the FDA for emergency approval of one of them.

    At least one is being manufactured at the New Jersey plant where FDA inspectors found oversight and drug control issues in November and August</p></div><p class=”mol-para-with-font”>’These findings do not impact product quality or patient safety, as outlined in a detailed assessment submitted to FDA,’ the company´s statement said.

    ‘Lilly continues to provide updates to the FDA on progress towards completion of our detailed plan.'</p><p class=”mol-para-with-font”>The drugmaker declined to provide a copy of the assessment it gave the FDA.</p><p class=”mol-para-with-font”>The FDA did not respond to requests for comment.

    The White House declined to comment.</p><p class=”mol-para-with-font”>One of the sources told Reuters that Lilly employees had complained about problems at the plant, including insufficient staffing and falsified records tracking whether workers had followed FDA manufacturing standards.</p><p class=”mol-para-with-font”>Lilly said the FDA has not made any findings of falsification at the site.</p><p class=”mol-para-with-font”>Out of 563 total inspections concluded in fiscal year 2019 by the FDA across the country, only a small fraction resulted in the most serious OAI classification, FDA data shows, and no other Lilly facility has received such a notice in at least 10 years.</p><p class=”mol-para-with-font”>None of Regeneron’s facilities have received OAIs based on inspections through the end of October 2019, FDA records show.

    Regeneron said in a statement it was ‘proud’ of the company´s efforts to comply with manufacturing requirements, which ‘is reflected in our FDA inspection record.'</p><p class=”mol-para-with-font”>Lilly has not disclosed the FDA inspections in its U.S. Securities and Exchange Commission filings.

    U.S. courts, in cases involving other companies, have ruled that such information could be material to investors. </p><p class=”mol-para-with-font”>But that depends on several factors, including the severity of the FDA´s findings, as well as whether the company has failed to correct the deficiencies.</p><p class=”mol-para-with-font”>In its statement to Reuters, Lilly did not respond to a question about why the inspections were’t disclosed.</p><p class=”mol-para-with-font”><span class=”mol-style-bold health-ccox mol-style-medium”>PRESSURE TO GET ANTIBODY TREATMENTS APPROVED BEARS DOWN ON DRUGMAKERS AFTER TRUMP SHIFTS ELECTION FOCUS</span></p><p class=”mol-para-with-font”>Trump had previously focused on a promise to deliver a coronavirus vaccine by the November 3 election, but that effort has since lost momentum due to doubts that any drugmaker will have enough proof of safety and efficacy in the coming weeks.</p><p class=”mol-para-with-font”>Now under increased pressure to act swiftly against the pandemic, the FDA has discretion to approve Lilly´s COVID-19 therapy for emergency use even if the manufacturing issues have not been fully resolved.</p><div class=”artSplitter mol-img-group” style=”style”> <div class=”mol-img”> <div class=”image-wrap”> President Trump has been pushing for emergency approval of both Eli Lilly's coronavirus antibody treatment, and Regeneron's antibody drug, which he received during his bout with COVID-19 (pictured: Trump upon his return to the White House from treatment at Walter Reed) </div> <noscript> President Trump has been pushing for emergency approval of both Eli Lilly's coronavirus antibody treatment, and Regeneron's antibody drug, which he received during his bout with COVID-19 (pictured: Trump upon his return to the White House from treatment at Walter Reed) </noscript> </div> <p class=”imageCaption”>President Trump has been pushing for emergency approval of both Eli Lilly’s coronavirus antibody treatment, and Regeneron’s antibody drug, which he received during his bout with COVID-19 (pictured: Trump upon his return to the White House from treatment at Walter Reed)</p></div><p class=”mol-para-with-font”>The FDA has already been criticized by some scientists and politicians for issuing EUAs for use of anti-malarial drug hydroxychloroquine and convalescent plasma treatment in coronavirus patients, despite little or problematic data.

    The agency ultimately withdrew its authorization for hydroxychloroquine and the plasma authorization remains in place.</p>

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