Argenx's Vyvgart gains commercial momentum in gMG as company plots expansion into new uses

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来源: FiercePharma

During a conference call Tuesday, CEO Tim Van Hauwermeiren said Argenx will use a priority review voucher to hasten an FDA decision on its submission for approval for Vyvgart to treat chronic inflammatory demyelinating polyneuropathy.

As Argenx works to grow the reach of its up-and-coming rare disease med Vyvgart, the company is seeing significant early gains for its lone commercial product. Up next, the drugmaker plans to deploy an FDA priority review voucher to speed the med's potential expansion into a new use.

Following an approval in June, uptake has been strong for the subcutaneous version of Argenx’s Vyvgart, the company said Tuesday, continuing the momentum for the game-changing product that is positioned to combat a variety of immunoglobin G-mediated autoimmune diseases.

Sales of Vyvgart, which was first approved by the FDA as an infusion in December 2021, reached $329 million in the quarter, a 151% increase year over year and a 22% boost from the previous quarter.

The neonatal Fc receptor antagonist is on its way to blockbuster sales in its second full year on the market, a significant accomplishment considering the modest size of the patient population of the lone disease it treats, generalized myasthenia gravis.

During a conference call Tuesday, CEO Tim Van Hauwermeiren said Argenx will use a priority review voucher to hasten an FDA decision on its submission for approval for Vyvgart to treat chronic inflammatory demyelinating polyneuropathy (CIDP).

“We feel a strong sense of urgency to bring our therapy to CIDP patients as quickly as possible,” Van Hauwermeiren said.

A recent trial in the indication showed that Vyvgart slashed the risk of relapse by 61% over placebo. Argenx said it will submit its application by the end of the year.

In June, Argenx scored its FDA nod for subcutaneous Vyvgart Hytrulo, allowing it to be provided by way of an injection, usually to the stomach, which takes between 30 seconds and 90 seconds. The new formulation gives patients an option to infusion.

Most of those who are opting for Vyvgart Hytrulo are new patients, as opposed to those who are switching, Karen Massey, Argenx’s chief operating officer, said on a conference call.

“By providing flexibility in how and where patients receive treatment, we are reaching a broader population, which is what we had hoped for,” Massey said. “We also continue to make progress shifting into earlier treatment lines, and Vyvgart Hytrulo is contributing to this expansion.”

Expansion is the buzzword these days for the Amsterdam-based company as it tries to pile on more indications for Vyvgart. The company is working on 13 indications for the drug, with more to be included by 2025, Van Hauwermeiren said.

Sales of Vyvgart reflect “the strong medical need in myasthenia gravis, the quality of the product and the excellent execution of the commercial rollout,” Damien Choplain, analyst with ODDO BHF, wrote in a note to clients. The ODDO BHF team predicts Vyvgart's peak sales will reach $13.6 billion in 2035.

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