Lundbeck blames FDA-imposed DTC blackout for slowdown in Rexulti growth

Lundbeck has learned an unwanted lesson in the value of DTC advertising. After pushback from the FDA forced Rexulti depression ads off the air, Lundbeck reported a flattening of prescriptions that appears to be rebounding now promotion has resumed.

The FDA took Otsuka, Lundbeck’s partner on Rexulti, to task in an untitled letter in October. According to the FDA, a major depressive disorder (MDD) efficacy claim that Rexulti ads made repeatedly from 2020 to 2023 overstated the impact of the drug. The agency closed out the untitled letter in December but it was another two months before DTC promotion of Rexulti in MDD resumed. 

Lundbeck management discussed the impact of the four-month DTC blackout on a first quarter earnings call Wednesday. Thomas Gibbs, head of Lundbeck in the U.S., said growth outside of Alzheimer’s disease moderated in the first quarter, a trend he attributed to the MDD campaign being off the air. 

“DTC is an incredibly important part of the element of our marketing mix, driving over a 2.8 ROI on a year-over-year basis, so that is where we think we had seen a flattening,” Gibbs said. Promotion in MDD, which represents around 38% of total brand prescriptions, resumed Feb. 26.

Ad spend data show Lundbeck and Otsuka returned to DTC promotion with gusto. Having slipped out of the top 10 TV drug ad spenders in February, Rexulti took third place on the list in March and climbed to the top spot in April. The partners ran a mix of Alzheimer’s and MDD TV spots, but the biggest outlay, an estimated $18.8 million in both months, was on the “Still Masking” depression ad. 

Lundbeck is seeing signs that coming back with a bang is paying off. Gibbs said there is typically a lag of six to eight weeks between running an ad and seeing its impact. By late April, Lundbeck was seeing total prescriptions “start moving up again,” the executive said. New-to-brand prescriptions, which Gibbs said is the most sensitive measure, hit an all-time high in Lundbeck’s latest data. 

Gibbs cited the trends since DTC advertising resumed as evidence that Lundbeck will be able to grow sales of Rexulti in MDD throughout the rest of the year. Asked about the chances of further FDA action, Gibbs said he is “incredibly” confident that Rexulti will avoid another letter because the teams received Office of Prescription Drug Promotion approval for the materials they rolled out starting Feb. 26.

Otsuka made no mention of an impact of the DTC blackout on Rexulti sales in its first-quarter earnings presentation (PDF) last month. The Japanese drugmaker named the disease awareness campaign for Alzheimer’s-associated agitation as a driver of 22% Rexulti sales growth in the quarter.