Editors' (re)View: Contraception gel less effective than claims; Can tirzepatide usurp Humira?

Nov. 10, 2023
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of November 6

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

About the Author

Andrea Corona | Senior Editor

Andrea Corona serves as the Senior Editor of Pharma Manufacturing — a leading source of news and insights for pharma professionals — and is responsible for creation of editorial content, moderating webinars, and co-hosting the "Off script" podcast. Her editorial journey started as an as associate editor at Biocompare, an online platform providing product information, industry news, articles, and other resources to support scientists in their work. Before Biocompare, she was a digital producer at Science Friday, focusing on adapting radio segments for the web and social media management. Andrea earned her bachelor's degree in journalism and biology from the State University of New York, at Purchase College. 
About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'