The other pivotal date in November
It has been 18 months since Biogen told the world its experimental treatment for Alzheimer’s disease had failed in late-stage trials and nearly a year since the company said, on second look, that the drug actually worked. Months of debate ensued, but missing from the conversation was the only opinion that really matters: that of the FDA.
That’s set to change. The agency issued notice yesterday that it will convene a panel of outside experts on Nov. 6 to discuss whether Biogen’s medicine, aducanumab, ought to be approved.
The meeting itself will likely be a fascinating (and presumably virtual) glimpse at how neurologists, statisticians, and patients look at Biogen’s controversial evidence for aducanumab. But the most important words may be those in the FDA-authored briefing documents that will become public in the days before the discussion. For the past year and a half we’ve had to rely only on Biogen’s descriptions of its meetings with the FDA. Soon we’ll get to read directly from the agency’s career scientists, who might prove to be far less sanguine than their peers in industry and academia.
That’s set to change. The agency issued notice yesterday that it will convene a panel of outside experts on Nov. 6 to discuss whether Biogen’s medicine, aducanumab, ought to be approved.
The meeting itself will likely be a fascinating (and presumably virtual) glimpse at how neurologists, statisticians, and patients look at Biogen’s controversial evidence for aducanumab. But the most important words may be those in the FDA-authored briefing documents that will become public in the days before the discussion. For the past year and a half we’ve had to rely only on Biogen’s descriptions of its meetings with the FDA. Soon we’ll get to read directly from the agency’s career scientists, who might prove to be far less sanguine than their peers in industry and academia.
Congress still wants answers on a handful of pricey drugs
A plodding House committee investigation is coming to a head this week with two days of drug pricing hearings that could prove perilous for the biopharma CEOs hauled in to testify.
As STAT’s Nicholas Florko reports, the House Oversight Committee has pored through some 1 million pages of internal documents from six drug makers over the past year. It’s unclear just what will be revealed during the hearings, scheduled for Wednesday and Thursday, but the list of drugs under investigation provides some clues.
Among the standouts is Revlimid, a Bristol Myers Squibb cancer drug that has long been a lightning rod for industry critics, who claim its inventors at Celgene gamed the FDA’s safety rules to stifle generic competition. A surprising omission is AbbVie’s Humira, a superlatively successful medicine that has gradually grown more expensive despite its key patents expiring years ago.
Read more.
As STAT’s Nicholas Florko reports, the House Oversight Committee has pored through some 1 million pages of internal documents from six drug makers over the past year. It’s unclear just what will be revealed during the hearings, scheduled for Wednesday and Thursday, but the list of drugs under investigation provides some clues.
Among the standouts is Revlimid, a Bristol Myers Squibb cancer drug that has long been a lightning rod for industry critics, who claim its inventors at Celgene gamed the FDA’s safety rules to stifle generic competition. A surprising omission is AbbVie’s Humira, a superlatively successful medicine that has gradually grown more expensive despite its key patents expiring years ago.
Read more.
The tortoise tells the tale
Last week STAT's Helen Branswell wrote about the potential for Covid vaccines from Sanofi and Merck to catch up with Pfizer and Moderna. Yesterday, Matt Herper wrote about the hurdles such vaccines will have to jump through in order to each the market early.
SVB Leerink analyst investor Geoffrey Porges has some interesting intel on both points. At the SVB Leerink Forum, Sanofi's John Shiver told Porges that the company believes that antibody levels — the traditional measure of a vaccine — will prove predictive with Covid-19, too. Sanofi aims to start a late-stage trial of its vaccine by the end of the year, and to make the product available in the first half of next year.
One worry from Herper's story is what happens if studies are unblinded — meaning patients in the placebo group get the vaccine — before full safety data are conducted. First of all, Porges writes, side effects from vaccinations usually occur within 45 days, and new safety events after two months are rare. If the placebo group gets vaccine, post-vaccination data can still be compared to data before vaccination. Long-term data on immune response will also be collected, and may become a surrogate for vaccine effectiveness. But Sanofi has another point: Its lead candidate, being developed with GlaxoSmithKline, is the only leading vaccine candidate with a safety record in marketed products.
SVB Leerink analyst investor Geoffrey Porges has some interesting intel on both points. At the SVB Leerink Forum, Sanofi's John Shiver told Porges that the company believes that antibody levels — the traditional measure of a vaccine — will prove predictive with Covid-19, too. Sanofi aims to start a late-stage trial of its vaccine by the end of the year, and to make the product available in the first half of next year.
One worry from Herper's story is what happens if studies are unblinded — meaning patients in the placebo group get the vaccine — before full safety data are conducted. First of all, Porges writes, side effects from vaccinations usually occur within 45 days, and new safety events after two months are rare. If the placebo group gets vaccine, post-vaccination data can still be compared to data before vaccination. Long-term data on immune response will also be collected, and may become a surrogate for vaccine effectiveness. But Sanofi has another point: Its lead candidate, being developed with GlaxoSmithKline, is the only leading vaccine candidate with a safety record in marketed products.
Inovio’s Covid-19 plans may be coming unspooled
Inovio Pharmaceuticals, among the darker horses racing to develop a vaccine for Covid-19, ran into an indefinite delay that could eventually derail its plans to compete with the likes of Moderna, AstraZeneca, and Johnson & Johnson.
Yesterday, the company said its planned pivotal trial was on hold after the FDA demanded more information on the vaccine, called INO-4800, and the electronic gadget Inovio uses to get its DNA-based injections into people’s cells. The company said it would respond to the agency’s questions some time next month, at which point the FDA would have 30 days to decide on whether Inovio’s study can proceed.
That means the best-case scenario for Inovio is a delay that extends into the winter, by which point the leaders in the vaccine field might already have interim data on their late-stage studies while more experienced firms will be starting sizable trials of their own. That might make enrollment difficult, to say nothing of Inovio’s ongoing legal issues with a contract manufacturer and the fact that the company has spent decades trying and failing to turn its technology into an approved product.
Yesterday, the company said its planned pivotal trial was on hold after the FDA demanded more information on the vaccine, called INO-4800, and the electronic gadget Inovio uses to get its DNA-based injections into people’s cells. The company said it would respond to the agency’s questions some time next month, at which point the FDA would have 30 days to decide on whether Inovio’s study can proceed.
That means the best-case scenario for Inovio is a delay that extends into the winter, by which point the leaders in the vaccine field might already have interim data on their late-stage studies while more experienced firms will be starting sizable trials of their own. That might make enrollment difficult, to say nothing of Inovio’s ongoing legal issues with a contract manufacturer and the fact that the company has spent decades trying and failing to turn its technology into an approved product.
More reads
- An FDA safety program is failing to stem the opioid crisis — and manufacturers are mostly to blame. (STAT Plus)
- What Trump’s Supreme Court pick could mean for science. (Nature)
- With a new law, California becomes the first state to pursue its own line of generics. (STAT Plus)
- Biogen loses appeal in patent fight seeking royalties on Rebif. (Bloomberg)
- FierceBiotech's 2020 Fierce 15. (FierceBiotech)
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