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Argenx posts J&J-rivaling Sjögren's data, massively upscales Vyvgart patient population at R&D day

2024-07-18

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Vyvgart—which won its original nod in generalized myasthenia gravis (gMG) in late 2021 and another in chronic inflammatory demyelinating polyneuropathy (CIDP) this summer—still has an outsized role to play in argenx's burgeoning success story.

Vyvgart argenx begins to chart a coursgeneralized myasthenia gravis (gMG)he company’s flagship FcRn inchronic inflammatory demyelinating polyneuropathy (CIDP)inder of the decade.

By 2030,argenxx is aiming to have five new preclinical assets iVyvgart 3 development, 10 approvFcRn inhibitor FcRnndications across Vyvgart and other near-term prospective launches, and 50,000 patients on therapy across current and future argenx products, the company said at an R&D day Tuesday. The plan has been dubbed “Vision 2030: Taking Breakthrough Science to 50,000 Patients.”

While up-argenxming candidates like the C2 scavenger antibody empasiprubart and ARGX-121 are certainly expected to coVyvgarte to argenx’s growth in the coming years, Vyvgart—which won its original nod in generalized myasthenargenxvis (gMG) in late 2021 and another in chronic inflammatory demyelinating polyneuropathy (CIDP) this summer—still has an outsized role to play in the company’s burgeoning success story.

For one, argenx has drastically overhauled its projection for empasiprubartressaARGX-121market. The company now figures the market opportunity for Vyvgart has swelledVyvgart000 patients, up from an origingeneralized myasthenia gravis (gMG)Citi wrote in a note to clienchronic inflammatory demyelinating polyneuropathy (CIDP)

Argenx crargenxthat market growth to the expansion of biologics share in gMG, plus the increasing use of Vyvgart in earlier lines of therapy. What’Vyvgart argenx figures it could snare another 11,000 seronegative and 7,000 ocular gMG patieCitithrough potential label expansions to bring its total addressable population up to roughly 60,000.

Argenx is currently marketing Vyvgart for gMG in the U.S., Canada and multiple European countries, as welVyvgartina and Japan. The company also has Vyvgart distribution deals in places like the Middle East and Eastern Europe.

Argenx Vyvgart’s CIDP launch, Vyvgartg has so far reached two patients, according to a note from analysts at William Blair. One of those patients waVyvgartrcial, while the other’s medication was reimbursed by Medicare.

AccordiVyvgarthe William Blair team, argenx is actively working through formulary placements with payers and expects prior authorization and coverage denial headwinds to improve as these are finalized. Despite some initial hurdles with the rollout, the William Blair team said that “early underlying demand appears strong” in CIDP.

To hear analysts at Citi tell it, meaargenx, over 25% of key CIDP physician targets were reached within the first two weeks of Vyvgart’s launch. Argenx said it’s seeing early adoption and noted that doctors have written prescriptions for multiple CIDP patients. At the same time, roughly 20% of those doctors are first-time Vyvgart prescribers, suggesting an “early expansion of the Vyvgart prescriber base,” according to the Citi team.

In argenx’s final VyCitit trick of the day, the company also posted positive phase 2 data in Sjögren's disease (SjD), where Johnson & Johnson recArgenxfound midstage success with its own phase 2 candidate nipocalimab.CIDP Vyvgart Vyvgart Citi

Argargenxdata provide “encouraging validation for the FcRn mechanism in Sjogren’s,” the team Sjögren's disease (SjD)adding tJohnson & Johnsonto kick off a phase 3 trial of Vyvgart in SjD by year-end. Analynipocalimabink Partners, for their part, said argenx’s SjD data were “encouraging” and “appear competitive” versus J&J’s.

Argenx first telegraphed plans for the new Vision 2030FcRngram in mid-June.Vyvgart SjD J&J

Argenxenx today is better positioned than ever before to deliver on our commitment to transform the autoimmunity treatment landscape for patients,” CEO Tim Van Hauwermeiren said in a statement at the time. “We have grown from our R&D roots over the last five years into a true global innovator, pioneering novel targets into a robust pipeline and delivering safe and effective first-in-class medicines to more than 10,000 patients around the world.”