Madrigal Pharmaceuticals is aiming to accomplish what has so far proven to be impossible: to bring a fatty liver drug across the FDA finish line and onto the market.
That hope, which could be worth billions of dollars, sits with its experimental drug resmetirom, which is currently being looked over by the FDA in nonalcoholic steatohepatitis (NASH).
The biotech is anticipating a decision from the U.S. regulator by next March, but it is already preparing for a potential approval and launch through a new awareness push.
Madrigal faces two main obstacles: enhancing understanding and education about NASH, a "silent disease" requiring a medical diagnosis, and navigating the restriction that, since the drug is not yet approved, the company cannot employ any branded campaigning.
What it has opted for, four months out from that potential approval, is a patient-focused disease awareness video called: “Meet Olivia, Her Liver’s #1 Fan.”
In the two-and-a-half-minute unbranded spot, we meet Olivia, a woman wearing her "happy liver" socks. We learn that she aims to raise awareness about liver health after undergoing a liver transplant, a risk faced by some NASH patients.
The first half-minute or so is quiet; we observe details of her liver transplant through news clippings and various items around her house as she prepares to go out. After lacing up her shoes, Olivia ventures outside and encounters two women engaged in a conversation about fatty liver disease. Overhearing, Olivia intervenes and says fatty liver disease “is not something to take lightly” and then makes a joke about pickles, when the women start talking about pickleball, showing the slightly comedic nature of the video.
Olivia then moves through her day, congratulating a man on ordering a nonfat drink in a coffee shop, and proceeds to give more details about NASH and its causes and mentions 90% of people with NASH “don’t even know they have it.”
The video plays as if people are not overly interested in hearing about the disease, perhaps a nod to the lack of awareness. We see, again with comedic undertones, Olivia sitting alone in a park being ignored with a banner reading: “Got NASH? Ask me about liver scarring.”
Slightly dejected, Olivia then goes for a coffee with her sign leaned up against her table. A man across from her then talks about the fact that his doctor has just spoken to him about NASH and that he feels “so overwhelmed,” where Olivia replies: “You’re not alone; believe me, I’ve been there,” at which she invites him over to talk.
The video ends by asking people to check for liver problems with their doctor, and, while there is a flash of Madrigal’s logo, there are no other brands or mentions of treatments.
This follows a typical pre-launch awareness push, where the idea is to focus on the disease and its patients and not on drugs or interventions.
This awareness push comes in the same month that Madrigal hired Carole Huntsman as its new chief commercial officer as it looks to tap her experience launching Sanofi and Regeneron’s megablockbuster immunity drug Dupixent for resmetirom.