Madrigal Pharmaceuticals’ March approval for its metabolic dysfunction-associated steatohepatitis treatment Rezdiffra marked a significant milestone. Not only was Rezdiffra the first drug to make it to market for Madrigal, it was also the first-in-disease approval for MASH, previously known as NASH, the most severe form of nonalcoholic fatty liver disease that affects an estimated more than 115 million people globally.
Since launching in April, Rezdiffra sales have already been promising, besting Wall Street analysts’ estimates during the second quarter of 2024 and generating $14.6 million in the U.S., Madrigal reported in its quarterly earnings. Despite the disease’s wide patient population, Madrigal is focused first on capturing 315,000 patients diagnosed with MASH with moderate to advanced liver fibrosis who are already under the care of a liver specialist.
That targeted patient population has been at the core of Madrigal’s marketing strategy and launch campaign, dubbed “Way Forward,” according to Kristin Bucklen, vice president of consumer marketing at Madrigal.
“We're not trying to drive the masses,” she said. “The intention to be so focused with a specific population is something that I think sets us apart from a lot of medicines.”
The campaign, which was “a year-plus in the making,” has been active for about six weeks, according to Bucklen. But it’s not just diagnosed patients Madrigal is aiming to reach.
“Our other target patient actually thinks they just have a fatty liver and don't realize they could already have [MASH], which is a much more serious condition with even more serious consequences,” Bucklen said. “They might not realize they have [MASH] because from the patient perspective, [it] didn't resonate. They didn't connect with the words [MASH]. They [are] more connected with this idea of, ‘it's just a fatty liver.’”
The two sets of patients have their own challenges for Madrigal to overcome. For those who know they have MASH, it’s about medication awareness.
“With Rezdiffra, part of the challenge is because [MASH patients have] been told that there hasn't been anything for them — all they had was diet and exercise — they don't know how to look.”
For patients who think they just have a fatty liver, Madrigal has to educate them about MASH, a more serious condition that, once understood, can kick patients into action to have treatment discussions with their doctor.
“It could progress to cirrhosis or liver transplant, which we have found is quite motivating for patients,” Bucklen said.
On the physician side, there is “an equivalent campaign” to ensure doctors know Rezdiffra is available and there is a MASH treatment option for the first time, Bucklen said.
Madrigal’s ‘way forward’
In order to reach its target patient population, Madrigal decided to go all digital in its initial campaign launch with targeted internet ads and connected TV spots.
“Our CEO has communicated very clearly that the overall research that's been done from a corporate perspective says there are approximately 315,000 patients in the U.S., so it just makes sense to be very focused and targeted,” Bucklen said.
When it came to messaging, Madrigal engaged “hundreds” of MASH and fatty liver disease patients and asked what they wanted out of a MASH treatment.
“What struck me is how hopeless patients said they felt in the absence of a medicine,” Bucklen said. “Frankly, diet and exercise is not very specific in terms of being actionable for patients.”
Patients overall said they felt stuck with their diagnosis and were looking for a way forward. That sentiment became the heart of the drug’s messaging.
“They said that they wanted to feel strength, control and confidence … so that they could do the things that they love with the people that they love,” Bucklen said.
Leveraging patient ambassadors, Madrigal hopes the ads will help other patients see the lived experience of MASH.
“I have [MASH], a serious form of fatty liver disease that’s scarring my liver,” a patient says in one of Madrigal’s ads. “I was doing all I could and it wasn’t enough.”
After Rezdiffra’s strong start in the U.S., Madrigal is pursuing commercialization in Europe as well, CEO Bill Sibold said in August, with an approval decision from the European Medicines Agency expected in mid 2025.
