Emergent secures mpox vax approval
Emergent BioSolutions has announced that its ACAM2000 vaccine, initially approved for smallpox, has received FDA approval for use in preventing mpox in high-risk individuals.
The expanded approval comes amid ongoing mpox outbreaks, particularly in Africa, where the WHO has declared a public health emergency. Emergent BioSolutions is actively engaging with global health authorities to support the response to these outbreaks, including a donation of 50,000 vaccine doses for deployment in Central Africa.
The approval is supported by existing human safety data and findings from a well-controlled animal study demonstrating that the ACAM2000 vaccine effectively protects against exposure to the mpox virus.
Mpox, formerly known as monkeypox, is a virus related to smallpox and is endemic to parts of Africa. The recent approval of ACAM2000 as a preventative measure for mpox underlines its potential as a key tool in controlling the spread of the virus, especially given its history as a descendant of the vaccine that eradicated smallpox.
This expanded use of the vaccine, combined with Emergent’s promise to donate 50k doses, is expected to play a crucial role in addressing the rising cases of mpox, particularly in regions experiencing severe outbreaks. — Andrea Corona
The DTC push
This week, we saw both Eli Lilly and Pfizer unveil updates regarding their previously announced direct-to-consumer platforms.
Eli Lilly said it will make single-dose vials of its blockbuster obesity drug, Zepbound, available through its platform, LillyDirect, which was launched in January.
For Lilly, the move seems to be strategic. With shortages of weight loss drugs rampant, compounded versions of Zepbound are flooding the market — and Lilly is looking to take back some of those customers. Through LillyDirect, a four-week supply of the 2.5 mg Zepbound single-dose vial will be $399, and a four-week supply of the 5 mg dose will be $549 – which, for those paying out of pocket, puts the Lilly drugs in the same price range as compounded versions.
It's a smart move and my first thought was, what is competitor Novo Nordisk going to do? Stay the course and keep fighting for coverage for its drug, Wegovy, or, put its own lower cost version on the market?
At the same time as the Lilly announcement, Pfizer launched its D2C digital platform, PfizerForAll. The end-to-end offering is designed to people an easier way to connect with a qualified health care professional the same day, book vaccines, receive tests and medications, and find savings and support if prescribed a Pfizer medicine.
Pfizer seems to be capitalizing on the widely accepted opinion that navigating the U.S. health care system is exhausting. An AAPA survey found that not only are U.S. adults spending an average of one working day per month coordinating care, but nearly 73% of U.S. adults report that the health care system is failing to meeting their needs.
Pfizer’s DTC service lets patients to use their existing insurance and offers live customer support to help users with the insurance coverage process.
Some are looking at the D2C push from pharma manufacturers as a sign that they understand their consumers. Patients either want to take a more active role in health care decisions — or have been forced to due to lack of health care resources — but either way, the industry seems to be attuned to that need. —Karen Langhauser