Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.
Revamped anthrax vaccine approval
When 63-year-old photojournalist Robert Stevens showed up to the hospital feverish in the middle of the night in late September of 2001, doctors assumed his symptoms were the culprit of a flu infection. But a few days later, his spinal fluid showed evidence of what was the first anthrax infection in the U.S. in 25 years. The attacks killed five and sickened 17, and prompted the U.S. government to seek immediate action to support the development of a safe and effective anthrax jab.
This week, we reported that Emergent BioSolutions' anthrax vaccine was approved by the FDA for post-exposure prophylaxis use in adults aged 18 through 65. Branded as Cyfendus, the vaccine is administered alongside recommended antibacterial drugs. Cyfendus is a two-dose anthrax vaccine that combines an older approved vaccine, BioThrax, with CPG 7909, an effective vaccine adjuvant that enhances the immune response.
The development of Cyfendus was supported by a $1.5 billion development and procurement contract with the Biomedical Advanced Research and Development Authority (BARDA) in 2016. In July 2019, BARDA exercised its first contract option to obtain vaccine doses. The vaccine had already been granted pre-Emergency Use Authorization status by the FDA, and the acquired doses were intended for inclusion in the Strategic National Stockpile over a period of 12 months.
While anthrax cases are rare, reports of infections earlier this year continue to highlight why immunization efforts should remain a priority.
— Andrea Corona
Hungry for solutions
This week we reported that the FDA added a fourth dose of Eli Lilly’s diabetes medication, Mounjaro, to its drug shortage database.
Of course, the supply issues for GIP and/or GLP-1 agonists are not new nor are they exclusive to Lilly. Novo Nordisk has been in the same boat with its diabetes med, Ozempic, the version approved for weight loss, Wegovy, and even its older weight loss drug, Saxenda. Novo went as far as to create a page on its website to keep patients updated on supply issues
Mounjaro, like Ozempic, is not approved for weight loss — but that doesn’t seem to matter to eager patients who are presumably using it off-label for its weight loss effects. In some situations its an insurance issue — insurers won’t cover obesity meds like Wegovy, but will cover type 2 diabetes meds (for patients with diabetes) such as Mounjaro and Ozempic.
Lilly recently shared impressive results from two phase 3 trials testing Mounjaro in overweight or obese patients without type 2 diabetes, and has initiated a rolling submission process with the FDA, which means Mounjaro will likely get the nod in obesity in the near future.
It’s an interesting problem for drugmakers to have — a product so effective and so popular that they have to halt promotional efforts (too bad the “Oh, oh, oh, Ozempic,” song is already in our heads). And with an enormous market, there is seems to be endless potential. It's estimated that 171 million people in the U.S. – more than half of the population — is obese or overweight.
The anti-obesity market — which Bloomberg Intelligence estimates could hit $44 billion by 2030 — has lured in the pharma industry. With countless GLP-1 agonists or combo drugs in trials, it begs the question if the next generation of these drugs will resolve some of the issues of the first gen — namely supply shortages, reimbursement and even side effects.
— Karen Langhauser