A little over a week after French regulators decided against authorizing Merck’s Covid-19 antiviral pill, the country has canceled its order, according to multiple reports.
A Merck spokesperson told Reuters that France’s planned purchase didn’t take place after the country’s health authority rejected the pill over growing concerns about efficacy and the impact of the Omicron variant. The country had pre-ordered enough doses to treat 50,000 patients.
Merck had originally said the Ridgeback Biotherapeutics-partnered drug, called molnupiravir, reduced the risk of death and hospitalizations by 50%. Then in late November, the company came back with updated data that suggested molnupiravir only cut the risk by about 30% compared to placebo.
Last month, the FDA’s Antimicrobial Drugs Advisory Committee voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms. But the FDA has yet to authorize the pill.
Yesterday, US regulators signed off on Pfizer’s Covid-19 pills, made up of nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use.
Pfizer’s pill, known as Paxlovid, proved to reduce the relative risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo in a trial of more than 2,000 people.
‘I don’t think you would find anyone who would prefer the Merck pill to the Pfizer pill, given the data evident so far,’ Walid Gellad, a professor of medicine at the University of Pittsburgh, told Endpoints News.
New study suggests Sinovac’s vaccine does not protect against Omicron
A new study conducted in China found that two doses and a booster of Sinovac’s vaccine, dubbed CoronaVac, did not produce adequate levels of protective antibodies against the Omicron variant.
The study, conducted by the University of Hong Kong and the Chinese University of Hong Kong, also found that two doses of the Pfizer/BioNTech vaccine, Comirnaty, produced poor antibody responses against Omicron. However, a third dose of Comirnaty given to those who received two doses of either Comirnaty or CoronaVac did produce protective levels, according to a news release by the University of Hong Kong.
‘Those who had received two doses of either Comirnaty or CoronaVac should get a third dose of Comirnaty vaccine around six months after their second dose of vaccine to achieve optimal protection against Omicron variant,’ professor Malik Peiris said in a statement.
Just a week ago, Sinovac claimed that a third shot of CoronaVac was 94% effective against Omicron, according to a report by Nikkei Asia.
CoronaVac was one of the first vaccines authorized for emergency use by the Chinese government, snagging an OK back in July 2020, an unnamed official told Reuters.
Sinovac has touted mixed results in the past, with Brazil’s Butantan Institute announcing a 78% efficacy rate back in January, then correcting that figure to 50.4% less than a week later. In February, trial results from Brazil and Turkey suggested CoronaVac prevented 50.65% of all Covid-19 cases, 83.70% of cases requiring medical treatment, and 100% of hospitalizations, and severe or fatal cases 14 days after the second dose was administered.
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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.
Khurem Farooq, Gyroscope CEO
Christmas is coming early for Gyroscope.
In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.
Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.
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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)
The centerpiece of Novartis’s $9.7 billion buyout of the Medicines Company can finally go to market.
Branded Leqvio, the small interfering RNA therapy long known as inclisiran is the first and only FDA-approved treatment to reduce LDL-C, i.e. bad cholesterol, with just two maintenance doses a year after an initial dose and another one at three months.
Touting a ‘revolutionary approach,’ Novartis CEO Vas Narasimhan noted that the approval ‘creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time.’ The label covers both atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia.
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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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The FDA on Wednesday signed off on Pfizer’s Covid-19 pills, which are meant to help keep people out of the hospital.
The news comes at a crucial moment, as the Omicron variant has taken over Delta as the prominent strain in the US, and as monoclonal antibody infusions will likely be in very short supply as two of the three currently marketed are ineffective against Omicron.
Pfizer will see early supply constraints of their pills, which are made up of nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use, meaning doctors will have to be very careful on how they’re doled out. And if Merck’s pill is authorized soon too, there may be more options, although there’s also a drastic difference in efficacy between the two.
Bob Baloh, Novartis Head of Neuroscience at NIBR (via Cedars-Sinai)
Even after agreeing to sell off $20 billion in shares back to Roche in November, Novartis got a bit more from its crosstown rival — successfully getting ahold of Roche’s head of neuro and rare disease R&D for themselves.
NIBR president Jay Bradner — a well-known name here at Endpoints — announced Bob Baloh’s appointment on Twitter. Baloh will be running NIBR’s neuroscience division.
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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.
Deck the halls with more appointments in the last Peer Review for 2021. Thanks for reading every week!
→ When the calendar flips to 2022, Joan Shen is out at I-Mab ‘to pursue other interests,’ leaving founder and chairman Jingwu Zang to succeed her as acting CEO in a bit of a surprise. Under Shen’s leadership, I-Mab formed a CD47 alliance with AbbVie in September 2020 with lemzoparlimab as the centerpiece, and a year later our Amber Tong detailed I-Mab’s aspirations for other comparable partnerships, notably for development of the CD73 antibody uliledlimab. Shen was one of our 20 Women in Biopharma R&D honorees this month.
As the FDA is poised to authorize the new Pfizer and Merck pills to treat those with Covid-19 who haven’t been hospitalized, Bloomberg reports that the US will only have limited supplies of each pill initially.
US officials said Americans should have nearly 400,000 courses of Merck’s pill available upon its authorization and 65,000 courses of Pfizer’s pill. By the end of January, the government expects 3 million Merck courses — its entire order — and 250,000 Pfizer courses. Merck’s pill has been shown to be less effective in early trials than Pfizer’s, although Merck did not test its pill head-to-head against Pfizer.
https://endpts.com/covid-19-roundup-france-cancels-order-on-mercks-antiviral-pill-report-new-study-suggests-sinovacs-vaccine-does-not-protect-against-omicron/
