Jun 11, 2021
Three members of FDA drug review panel resign over approval of $56K Alzheimer’s drug
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Three scientists on the Food and Drug Administration’s independent panel of drug safety advisers have resigned over the agency’s decision to approve an Alzheimer’s drug they argue has not been proven to benefit patients.
“Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval,” said Dr.Aaron Kesselheim, a professor of medicine at Harvard Medical School, on Monday after the drug was approved.
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Kesselheim resigned from his position on the FDA’s Peripheral and Central Nervous System Advisory Committee on Thursday, which voted against approval of the intravenous drug Aducanumab in November 2020 — 10 members objected to approval, while one person abstained. Members of the panel argued the drug’s clinical trial results produced flimsy evidence that it would slow cognitive decline seen in patients with the degenerative disease.
The FDA’s Monday approval of Aducanumab, christened Aduhelm by biotech giant Biogen, is considered “accelerated,” meaning the company will have to produce results from a post-market study to prove efficacy. The treatment is a monoclonal antibody taken intravenously every month. It clears a “sticky” plaque in the brain made up of the protein beta-amyloid, which accumulates in the brains of Alzheimer’s patients and is believed to cause memory and cognitive problems. However, trial results did not provide proof of a clear benefit against the progression of the disease.
It is the first Alzheimer’s treatment to be approved by federal regulators in 18 years, and doctors are eager to have another available treatment for their patients. Still, scientists are doubtful that it can produce results.
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Kesselheim was the third member of the panel to resign after Mayo Clinic neurologist Dr. David Knopman quit Wednesday and Washington University neurologist Dr. Joel Perlmutter on Tuesday, Reuters reported.
“I was very disappointed at how the advisory committee input was treated by the FDA,” Knopman told Reuters on Wednesday. “I don't wish to be put in a position like this again.”
The treatment’s high price tag of $56,000 per year would drive up Medicare premiums across the board. The cost is also a sticking point for seniors covered by the government health plan, who could face copayments of up to $11,500 annually, according to the Associated Press.
News Source: washingtonexaminer.com
Novavax says its Covid vaccine is 90% effective, plans to submit data to FDA in third quarter
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Biotech firm Novavax said Monday its Covid-19 vaccine was shown to be safe and 90.4% effective overall in a phase three clinical trial of nearly 30,000 participants across the United States and Mexico.
Additionally, the two-dose vaccine was found to be 100% effective in preventing moderate and severe disease and 93% effective against some variants, Novavax said. The company said it plans to file for authorization with the Food and Drug Administration in the third quarter of this year.
The late-stage trial "confirms that NVX-CoV2373 offers an encouraging tolerability and safety profile," Dr. Gregory Glenn, Novavax's president of research and development, said in a press release. "These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus."
The analysis evaluated 77 confirmed Covid infections among the trial's 29,960 participants. Novavax said 63 cases of Covid were observed in the placebo group versus 14 cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 90.4%, it said.
The vaccine also appeared to be well-tolerated, according to the company. The most common side effects were fatigue, headache, muscle pain and pain at the injection site, which usually lasted no more than two or three days, the company said.
All Covid hospitalizations in the trial occurred in the placebo group, the company said.
Novavax said the vaccine appears to be effective against some variants, including the Alpha variant, first identified in the U.K. About 65% of the cases where sequence data was available were variants of concern, the company said.
If Novavax's vaccine is authorized by the FDA, it would follow three Covid-19 shots already approved for emergency use in the U.S. from Pfizer-BioNTech, Moderna and Johnson & Johnson.
The new data comes as federal officials say the U.S. has more than enough doses of Covid vaccines to finish vaccinating the entire American population. As of Sunday, more than 173 million Americans have had at least one dose of a Covid-19 vaccine, according to data compiled by the Centers for Disease Control and Prevention.
It's possible the U.S. could end up donating doses of the Novavax vaccine.
The Biden administration has already committed to donating at least 20 million doses of Covid vaccines produced by Pfizer-BioNTech, Moderna and J&J as well as 60 million doses of AstraZeneca's vaccines, which has not yet been authorized for use in the U.S.
Earlier this month, the White House announced it was lifting restrictions as part of the Defense Production Act that gave the U.S. priority for vaccines developed by AstraZeneca, Sanofi and Novavax.
Novavax said Monday it remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the fourth quarter of 2021.