CSL Behring has identified what it will take to win in a major autoimmune market. Ahead of a potential approval of argenx’s rival drug, the company surveyed people with chronic inflammatory demyelinating polyneuropathy (CIDP)—and emerged with evidence of an appetite for more convenient treatments.
The existing treatment options in CIDP include a pair of CSL products, the intravenous Privigen and the subcutaneous, self-administered Hizentra. Use of Hizentra is limited to maintenance therapy. Later this year, argenx expects to win FDA approval for Vyvgart Hytrulo, a subcutaneous product with a different mechanism of action. The drug will provide competition to products that drove growth at CSL last year.
CSL commissioned Harris Poll to help understand what factors will determine the winners of the next era of the CIDP market. The survey included 100 people living with the condition, including 98 who were on treatment, and 100 specialist physicians who regularly see at least one CIDP patient.
Most (82%) patients are interested in exploring more convenient treatment options. Administering the drug at home, something made possible by Hizentra, is extremely or very important to 72% of the respondents. Home administration trailed the three non-negotiables—efficacy, minimal side effects and condition maintenance—on the list of priorities when patients consider new therapies.
While patients are open to new therapies, some encouragement and education may be needed to get people to seek out alternatives to their current treatments. Less than half of the respondents discuss new treatment options and switching drugs with their physicians, and similarly few people have a good grasp of how different therapies work and are administered.
CSL, which is set to start selling a higher dose of Hizentra, is pitching its subcutaneous product as the answer to demands for more convenient treatment options. Argenx’s FcRn drug Vyvgart Hytrulo, which is given subcutaneously but must be administered by a healthcare professional in its existing indication, is on track to win approval in CIDP and launch in the U.S. around the middle of the year.
At an investor event in October, Andy Schmeltz, executive vice president of the CSL Behring business unit, said he expects Privigen and Hizentra “to maintain compelling leadership positions in CIDP and in all core indications given their well-established and well characterized benefit risk profile, their proven long-term protection, physician clinical experience and strong placement in treatment guidelines.”
Schmeltz added that “in CIDP, in particular, we look forward to competing with FcRns, both offensively and defensively, reinforcing the compelling benefit risk profile of Ig therapy.” CSL has a lot riding on the products. Privigen and Hizentra brought in (PDF) $2.8 billion and $1.6 billion, respectively, in the year ended 30 June. The figures represented 29% growth for Privigen and 12% growth for Hizentra.