Amgen’s roller coaster ride known as Tepezza is ascending again. Is the thyroid eye disease (TED) treatment finally gaining momentum that is sustainable?
In the second quarter, Tepezza generated $479 million in sales for an increase of 8% year over year and 13% sequentially. It was Tepezza’s highest quarterly sales figure since the fourth quarter of 2022.
As the lone treatment for TED, Tepezza has had an unusual trajectory. After Horizon Therapeutics pushed it across the FDA finish line with its landmark approval in 2020, Tepezza became a blockbuster in its first full year on the market as sales reached $1.7 billion in 2021, followed by a $2 billion haul in 2022—no small feat given that these were the difficult times of COVID lockdowns.
But, after peaking at $616 million in sales in the third quarter of 2021, Tepezza hasn’t approached that figure since. With its lack of experience in commercializing a blockbuster, Horizon shouldered some of the blame before it was scooped up by Amgen in a $27.8 billion buyout, which was complete in October of last year.
TED is a market that remains largely untapped. Of the roughly 100,000 patients who have the disorder, less than 10% have used Tepezza.
During a conference call, Amgen’s global commercial operations and medical affairs chief Vikram Karnani said the company still sees a “significant growth opportunity in the U.S.” and is working with ophthalmologists and endocrinologists—as opposed to just oculoplastic surgeons—to attract new customers.
“The impact of thyroid eye disease on quality of life is often underestimated,” Karnani said. “So, our focus is on educating healthcare providers about the significant effects on patients, even those with less visible symptoms.”
Amgen also has improved access to Tepezza as payers have come to recognize its efficacy, Karnani added.
“To date, we have achieved favorable medical policy changes for greater than 65% of U.S. covered lives,” Karnani said. “And, if you compare that to 50% last quarter and just over 5% about a year ago, I think we’ve made pretty good progress in enabling patient access using our phase 4 data that became available last year.”
A phase 3 study of a subcutaneous version of Tepezza also is underway. The formulation would remove some of the inconvenience of how the drug is administered, which is eight infusions, three weeks apart, each lasting between 60 minutes and 90 minutes. A subcutaneous dose can be given in less than five minutes.
Amgen expects to launch Tepezza next year in Japan, which CEO Robert Bradway called an “attractive market.” Amgen also has filed applications for the approval of Tepezza in Europe and the U.K.
Tepezza wasn’t the only product acquired from Horizon that was a big gainer in the second quarter. Gout treatment Krystexxa achieved a sequential increase from $235 million in the first quarter to $294 million, while optica spectrum disorder drug Uplizna went from $80 million in the first quarter to $92 million in the second quarter.
Overall for the quarter, Amgen reported revenue of $8.4 billion, which was a 20% increase year over year. Excluding sales of drugs gained from the Horizon buyout, Amgen still had a 5% increase thanks to its foursome of growth products.
Osteoporosis treatment Evenity rang up $391 million in sales for a 39% increase. Cholesterol drug Repatha generated sales of $532 million for a 25% increase. Asthma drug Tezspire pulled in $234 million for a 76% increase, while cancer treatment Blincyto achieved sales of $264 million, which was up 28%.
Extensive-stage small cell lung cancer drug Imdelltra, which was approved in May, had sales of $12 million.
“We are extremely pleased with how thought leaders and community oncologists are receiving Imdelltra in the market,” Murdo Gordon, Amgen’s global commercial operations chief, said. “Their clinical conviction is very high. They are moving quickly to establish care pathways for these patients given the monitoring requirements.”
Among Amgen’s older products—which will lose exclusivity before the end of the decade—osteoporosis drug Prolia was the company’s top seller at $1.2 billion for a 13% increase. Rheumatoid arthritis treatment Enbrel was down 15% to $909 million for the quarter.