US FDA approves syringe version of Argenx’s immune disorder drug
The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE’s (ARGX.BR), opens new tab blockbuster immune disorder drug, Vyvgart, giving patients a more convenient option of at-home self administration, the company said on Thursday.
U.S.-listed shares of the company rose 8.8% in extended trading.
Investors have been keeping a close eye on FDA’s decisions to make sure it is adhering to target dates for approvals, after mass firings at the regulator stoked worries about the potential erosion of its drug review system.
Last week, the FDA missed its deadline to issue a decision on granting a traditional approval for Novavax’s (NVAX.O), opens new tab COVID-19 vaccine.
The prefilled syringe version was approved to treat adult patients with a muscle-weakening genetic disease called generalized myasthenia gravis (gMG) and another rare, immune-mediated nerve disorder called chronic inflammatory demyelinating polyneuropathy (CIDP), the company said.
The drug is already approved as an under-the-skin injection, branded as Vyvgart Hytrulo, and in intravenous form to treat gMG and CIDP. Vyvgart Hytrulo uses the active ingredient efgartigimod and Halozyme Therapeutics’ (HALO.O), opens new tab drug delivery system.
Argenx said the Vyvgart Hytrulo prefilled syringe will be available within the next two weeks and that it would have a comparable price to the subcutaneous vial.
“The new version is going to make the drug more accessible and grow the market both on the patient level and on the prescriber level,” said TD Cowen analyst Yaron Werber.
The subcutaneous version is usually administered at an infusion center or a doctor’s office in the U.S. as it requires a healthcare professional to monitor any allergic reactions.
The self-injection option would allow Argenx to more effectively compete with the available oral treatments and drive the use of the drug to earlier lines of treatment, CEO Tim Van Hauwermeiren said.
Argenx recorded global sales of $2.2 billion from both approved versions of Vyvgart last year.
