Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.
FDA says Evofem contraception gel is not as effective as advertised
Phexxi, launched in the U.S. in September 2020, is the first and only non-hormonal, prescription contraceptive gel approved by the FDA.
But this week, the agency raised concerns to the drug's manufacturer, Evofem, pointing out that the promotional materials make misleading claims about the vaginal gel’s efficacy in preventing pregnancy. Specifically, the FDA highlighted that the 99% pregnancy prevention rate emphasized in the brochure is based on an unvalidated measure that assumes a consistent likelihood of pregnancy throughout the menstrual cycle.
The FDA stated that this method overestimates the contraceptive effect of the gel, and that Evofem should use validated endpoints, such as the Kaplan-Meier life-table analysis and the Pearl Index to provide a more accurate assessment of cumulative failure rates over specific lengths of exposure.
Evofem has puts most of its eggs in the Phexxi basket. Earlier this year, the California-based drugmaker said it was implementing cost-cutting measures to achieve cash flow neutrality by year-end and focus on the advancement of Phexxi, which included a reduction in the CEO’s salary.
Now, Evofem has 15 days to respond to the agency.
— Andrea Corona
The market’s new heavyweight?
This week, Eli Lilly's tirzepatide injection snagged a coveted, yet not unexpected, approval in chronic weight management in adults with obesity or overweight.
Analysts have been all over this drug following its May 2022 approval as Mounjaro in type 2 diabetes. (The weight loss version will be branded Zepbound, which I find oddly difficult to pronounce.) In a bold prediction, analysts have said tirzepatide has the potential to usurp Humira to become the best-selling drug of all time. According to UBS analyst Colin Bristow,the drug is expected to generate annual sales of $25 billion. Bank of America analyst Geoff Meacham estimates that annual sales could hit a $48 billion. Either way, the figure would exceed the previous record of $20.7 billion set by AbbVie's Humira in 2021.
Why I certainly don’t doubt the incredible efficacy and market need for tirzepatide (see our recent cover story for more on this), the suggestion alone that any drug could take on a behemoth like Humira in terms of sales is impressive. Consider that, Humira is more expensive per year than tirzepatide and has far more approved indications in far more places. [Maths: List price for a month’s supply of Humira — $6,922; List price for a month’s supply of Zepbound — $1,059.87. Humira is approved in 90 countries, tirzepatide (so far) in 1; Humira is approved in 14 indications, tirzepatide in 2]
That said, tirzepatide is off to an impressive start — the drug has only been on the U.S. market for 5 quarters and has already made $3.2 billion. And the potential for the drug is seemingly endless. In weight loss alone, more than half the world is overweight or obese and the global market is projected to hit $100 billion in sales by 2030.
Humira, now off patent, was still the second-best selling drug in the world in the first half of 2023. It's estimated that it will amass a revenue of $240 billion by 2024 – so it will definitely be interesting to see if, or perhaps how quickly, tirzepatide gets there.
—Karen Langhauser
