| | | |   | Good morning, everyone. Damian here with more on a weighty FDA decision, a referendum on mRNA, and what it's like to be a patient in the lecanemab study. | | | A test for the FDA commissioner The biggest test of the FDA’s authority in recent memory will soon come down to Commissioner Robert Califf, after the agency convinced a panel of outside advisers that a controversial medicine should be pulled from the market.
As STAT’s Ed Silverman reports, a group of external experts voted 14-1 in favor of the FDA’s effort to revoke the approval of Makena, a treatment meant to prevent preterm births. The drug won accelerated approval in 2011 based on preliminary evidence but failed to show any benefit in a confirmatory study disclosed in 2019, leading the FDA to call for its removal from the market. Covis Pharma, the manufacturer, contested that decision, leading this week’s three-day hearing.
Now that the FDA has the blessing of its advisers, the fate of Makena rests with Califf and the agency’s chief scientists, who are expected to take up to six months to render a decision. At stake is the FDA’s authority to enforce the rules of accelerated approval, which has come under scrutiny amid allegations that the drug industry has exploited the program at the expense of public health.
Read more. | For patients in the lecanemab study, hope and sense of gratitude Last month’s surprising news that lecanemab, an Alzheimer’s disease treatment from Biogen and Eisai, met its goals in a pivotal trial provided some hope to the millions of people affected by the disease. But for the select few patients enrolled in the study — the first clearly positive Alzheimer’s trial in two decades — that relief came with a sense of gratitude.
As STAT’s Andrew Joseph reports, the roughly 1,800 people in lecanemab’s Phase 3 study got early access to a treatment that might not be available to others until well into 2023, should the FDA approve it. It’s like “being able to be in the front of the line for what may be a major change for everyone who has my problem,” as one trial participant put it.
They don’t yet know whether they got lecanemab or placebo for the 18 months of the trial, but every patient has since had the opportunity to get on the drug for an extension study. And while the results of the trial — a 27% improvement over placebo — are fairly modest, “if it means a few more weeks, a few more months, at the human level, that’s going to be significant,” one patient said.
Read more. | Delivering on the patient experience in the age of Web3 and the Metaverse As patients seek tools to better understand their health and as providers look for ways to optimize care delivery, Web3 sits at the intersection of the entire experience. Whether you serve the needs of pharma, biotech or life science communities, Web3 will push the limits of what we thought possible. How brands tell their story in these new environments will make the difference between staying ahead of the curve or being left behind. Read the full story to begin planning for the future of content marketing and authentic storytelling. | Novavax can’t catch a break After a lengthy delay, Novavax finally won FDA authorization for its Covid-19 booster yesterday, but the fine print suggests only a small number of people might actually get the company’s last-place product.
As STAT’s Helen Branswell reports, the FDA signed off on the use of Novavax’s vaccine as a booster only for adults who, for medical or accessibility reasons, cannot take one of the bivalent boosters from Moderna and partners Pfizer and BioNTech, or who otherwise wouldn’t get one. And unlike the other Covid vaccines, Novavax’s shot can only be used as a first booster shot; anyone who has already had one or multiple boosters can only get the others.
The FDA’s restrictive wording further limits the revenue potential of Novavax’s vaccine, which proved dramatically effective in clinical trials but has been beset by delays. Novavax is working on a bivalent booster shot of its own, but data from an ongoing study, promised for September, are yet to materialize.
Read more. | The next mRNA referendum After its superlative success in Covid-19, Moderna’s next act is a vaccine for the common respiratory syncytial virus, and the company is betting its now-famous technology will give it a competitive advantage.
Moderna expects data from a roughly 24,000-person study of its RSV vaccine some time this winter. Earlier this year, two vaccines from Pfizer and GSK succeeded in pivotal studies of similar size, and each is expected to win approval. If Moderna can come through with data on par with its rivals, as is widely expected, the company expects to claim a “technology advantage,” management told Cowen analyst Tyler Van Buren, based on mRNA’s star turn during the pandemic.
Moderna’s logic is the inverse of the bull case for Novavax, whose Covid-19 vaccine used a more familiar technology and was thus theoretically more desirable than newfangled shots based on mRNA. That didn’t exactly play out. But the pandemic triumph of mRNA might not predict the market for RSV vaccines. For Covid, mRNA vaccines were the first to become available, and safety concerns derailed demand for a competing shot from Johnson & Johnson, giving Moderna and rivals Pfizer and BioNTech the lion’s share of demand before Novavax even arrived. By contrast, the coming RSV vaccines are likely to arrive more or less at the same time, providing a real test of whether consumers will opt for mRNA when older fashioned products are available. | More reads - What the Makena vote means about accelerated approval, trust, and the FDA, STAT
- A startup plans an IPO to give a shelved Lilly drug another shot, BioPharma Dive
- Large insurer’s decision to cover some prescription digital therapies may be a milestone for app makers, STAT
| Thanks for reading! Until tomorrow,  | | | |
No comments