New research from Johns Hopkins shows convalescent plasma may work in the outpatient space, which could be key as the Omicron variant has extinguished several monoclonal antibody treatments.
The results of this placebo-controlled, multicenter trial led by Hopkins researchers showed that convalescent plasma reduced the need for hospitalization among more than 1,000 outpatients with Covid-19 who participated.
The study found that 17 patients out of 592 (2.9%) who received the high-titer convalescent plasma required hospitalization within 28 days of their transfusion, while 37 out of 589 (6.3%) who received placebo control plasma also were hospitalized. The results open the door for a new population who may benefit from convalescent plasma (the current EUA is just for hospitalized Covid patients), even as the WHO has rallied against the use of convalescent plasma to treat Covid.
Arturo Casadevall, a co-author of the study and professor at Hopkins, told Endpoints News that based on the results from this study, published as a preprint on Tuesday, the FDA could move quickly to authorize the infusions for outpatients.
Co-author David Sullivan, professor of molecular microbiology and immunology at the Johns Hopkins, also noted in a press conference that the FDA is reviewing this new data.
‘How long this could take? Could happen very rapidly depending on how rapidly the USG [US government] moves – matter of days to weeks,’ Casadevall said via email.
But he also noted that ‘we won’t have a supply of omicron convalescent plasma for 4-6 weeks since we need convalescents and they must be fully healed. However, we have an alternative: people who had COVID who then were vaccinated have very high titers of antibody that neutralize omicron (preprint attached). Since we have large numbers of donors in this category we can treat people right away.’
The Hopkins study, funded by the US Department of Defense, also shows that convalescent plasma could help to replace the monoclonal antibodies from Regeneron and Eli Lilly that aren’t effective against Omicron, but which helped to keep high-risk people from the hospital while the Delta variant was dominant.
‘Now that omicron has defeated most of them we have lost a major line of defense to protect people from getting worse and to protect the hospitals from over-crowding. You can move convalescent plasma to the outpatient space, dispense it in infusion centers being used to treat patients and have CP compensate for the loss of mAbs. Basically, you are replacing one antibody therapy with another,’ Casadevall added.
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)
In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.
The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.
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The FDA may soon sign off on two new pills from Merck and Pfizer to help treat Covid-19 before those infected end up in the hospital, according to a Bloomberg report.
An announcement from the agency may come as early as Wednesday, according to three Bloomberg sources, which would create more options for those who are unvaccinated and need quick and early treatment.
Most recently, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the Merck pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms. But Merck offered little explanation for why its potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, and mutagenesis concerns remain.
Angie You and Volker Schellenberger, Amunix
Sanofi is crashing the year-end M&A party with a deal of its own.
Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’
‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’
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Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.
Late last month, the federal government paused shipments of GlaxoSmithKline and Vir’s mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren’t effective against Omicron.
Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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A long-acting injectable treatment for the prevention of HIV has been given the go-ahead by the FDA for use in adults and children weighing at least 77 pounds.
Apretude is first given as two injections given a month apart from each other, and then every two months after. Patients are given the option to start treatment with Apretude or the oral cabotegravir Vocabria for four weeks to assess how well to tolerate the drug.
A young man with Duchenne muscular dystrophy has died in Pfizer’s Phase Ib trial of its mini-dystrophin gene therapy, triggering a halt in screening and dosing — and a clinical hold imposed by the FDA.
Pfizer informed the Parent Project Muscular Dystrophy of the death in a community letter. The patient was participating in the non-ambulatory cohort of the trial, the company wrote, adding:
At this time, we do not yet have complete information and are actively working with the trial siteinvestigator to understand what happened.
https://endpts.com/with-few-treatment-options-for-omicron-convalescent-plasma-is-ready-for-a-comeback-will-the-fda-be-on-board-with-outpatient-use/
