Following last week’s R&D day, argenx continues to demonstrate that its flagship drug, FcRn inhibitor Vyvgart, has plenty of room to grow in its inaugural generalized myasthenia gravis (gMG) indication.
For 2024’s second quarter, infused Vyvgart and its subcutaneous sibling Vyvgart Hytrulo brought home $478 million in sales, up nearly 56% from the sum the medication generated over the same stretch in 2023. Thanks to that “reassuring” performance, argenx is now “firm on the path to profitability,” analysts at ODDO BHF wrote in a note to clients Thursday.
In the U.S. specifically, Vyvgart snared $407 million in the second quarter, handily beating consensus estimates of roughly $364 million, according to analysts at Evercore ISI. Breaking down the numbers, the Evercore team figures that at an average net price of around $225,000, there are around 7,250 U.S. gMG patients on Vyvgart today.
That stacks up nicely when compared to AstraZeneca’s rival meds Ultomiris and Soliris. Together, those brands also beat consensus with $950 million in the U.S. across all indications, but only about one-third of that sum—or about 2,900 patients—came from gMG, the Evercore team figures.
Overall, the Evercore analysts think there are roughly 11,000 U.S. patients on branded gMG drugs today. They figure the cumulative patient numbers could double and that the market could reach a value of $6 billion in the coming years.
Argenx posted its second-quarter results shortly after rolling out its new company strategy, Vision 2030, at last week’s R&D day, during which the company laid out goals to have five new preclinical assets in phase 3 development, 10 approved indications for Vyvgart and other near-term prospective launches ready by the start of the new decade.
During the event, argenx pointed to promising candidates in its pipeline such as the C2 scavenger antibody empasiprubart. Still, the company showed plenty of love for Vyvgart, which recently expanded into a second indication thanks to an FDA nod in chronic inflammatory demyelinating polyneuropathy (CIDP).
Notably, argenx drastically overhauled its projection for the total addressable gMG market. The company now expects that Vyvgart could eventually capture some 42,000 patients worldwide, up from an original estimate of 17,000, according to a note from Citi analysts last week.
Should the company expand Vyvgart to include seronegative and ocular gMG patients, as well, that potential pool could swell to roughly 60,000 patients.
Also of note, argenx is attempting to resurrect Vyvgart’s chances in immune thrombocytopenia (ITP), where the drug previously stumbled in November.
At the time, the company revealed that the subcutaneous version of the drug, Vyvgart Hytrulo, flunked both its primary and secondary endpoints in a late-stage study in the rare bleeding disorder. In the trial, patients on placebo experienced better blood clotting than those on Vyvgart Hytrulo.
Despite that miss, Vyvgart has managed to snare a lone ITP nod in Japan.
Now, following a meeting with the FDA, argenx expects to kick off a confirmatory study of infused Vyvgart in primary ITP “by the end of 2024 to enable registration in the U.S.,” the company said in its Thursday press release.
Argenx is currently marketing Vyvgart for gMG in the U.S., Canada and multiple European countries as well as China and Japan. The company also has Vyvgart distribution deals in places like the Middle East and Eastern Europe.
As for Vyvgart’s CIDP launch, the drug has so far reached two patients, argenx noted at its R&D day. One of those patients was covered by commercial insurance, while the other’s medication was reimbursed by Medicare.