Not only did BioCryst recently storm the hereditary angioedema (HAE) market with the first oral treatment for the disorder, the North Carolina biotech priced it lower than the premiere competitors from Takeda and CSL Behring.
Now, one of those competitors is retaliating, unveiling data that show the durability of its therapy.
In the long-term extension of a phase 3 study, Takeda’s Takhzyro showed that it retained its initial efficacy and safety in patients for up to 2.5 years and that reductions in attacks were consistent across patient demographics and disease characteristics.
HAE is a rare, lifelong disorder that causes rapid swelling of the hands, feet, limbs, face, intestinal tract or airways. It affects approximately one in every 50,000 people.
In the first analysis of Takhzyro study, the average reduction rate of angioedema attacks compared to baseline was 87.4%. For the long-term follow-up, HAE attacks were measured at Day 70 to the end of the 2.5-year treatment period of the drug given every two weeks, and attack rates were further reduced to an average of 92.4%.
The data were presented this weekend during the European Academy of Allergy and Clinical Immunology Hybrid Congress.
Among eight drugs on the market for HAE, CSL Behring’s Haegarda, which was approved by the FDA in 2017, and Takhzyro, which was endorsed the following year, have become the favored treatments. But that could change quickly with the arrival of BioCryst’s Orladeyo.
In December 2020, Orladeyo became the first oral treatment for the disorder and is taken once daily. The approval prompted Evercore ISI analyst Liisa Bayko to write that Orladeyo could reach a third of the preventive HAE market by the end of 2021, and its sales could hit $300 million by 2023.
In the October-December 2020 period, Takeda reported quarterly sales of $210 million for Takhzyro. Privately held CSL Behring does not report sales for individual products, but, a year after winning approval for Haegarda, the company claimed the drug had taken approximately 50% of the market share in the U.S. for HAE prevention.