FDA Approves Subcutaneous Vyvgart Hytrulo for Generalized Myasthenia Gravis
The drug is also approved for adults with chronic inflammatory demyelinating polyneuropathy.
The FDA approved a self-injectable efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) as a prefilled syringe for the treatment of adults with generalized myasthenia gravis (MG) who are anti-acetylcholine receptor antibody positive and for adults with chronic inflammatory demyelinating polyneuropathy (CIDP).1
The drug is also approved for adults with chronic inflammatory demyelinating polyneuropathy. | Image Credit: Olivier Le Moal - stock.adobe.com
“Today’s FDA approval provides a new self-injection option across both approved indications in the US that is designed for patients who seek more independence with their treatment,” Luc Truyen, MD, PhD, chief medical officer at argenx, said in a news release.1 “We understand patients experience MG and CIDP in different ways, and our prefilled syringe is an important innovation that provides patients with more freedom and flexibility to self-administer Vyvgart Hytrulo. Whether patients prefer to receive their treatment in a physician’s office, at home, or while traveling, they can experience treatment on their own terms and continue to benefit from Vyvgart Hytrulo’s favorable safety profile and strong efficacy.”
MG can cause muscles to feel weak and get tired quickly, and there is currently no cure for the disease. Treatment can help with symptoms, such as weakness of arm or leg muscles, double vision, drooping eyes, and issues with swallowing, chewing, breathing, or speaking, according to Mayo Clinic. CIDP is a neurological disorder where there is inflammation of nerve roots and peripheral nerves. It also includes the destruction of the myelin sheath of the nerve fibers and can cause weakness, paralysis, and impairment of motor function, especially in the arms and legs.2,3
The prefilled syringe is approved as a 20-to-30-second subcutaneous injection administered by either the patient, caregiver, or health care professional. The approval was based on data from studies that evaluated the bioequivalence of the drug compared with the vial formulation.1
In previous studies, the intravenous formulation showed positive effects of the drug for both GM (NCT03669588) and CIDP. In the MG study, there were 167 patients included who received randomized treatment with either the study drug or the placebo. At baseline, approximately 80% of patients in each group received AChE inhibitors, over 70% received steroids, and 60% received NSISTs. There was a statistically significant difference for the study drug in the MG-ADL responder rate during the first treatment cycle compared with the placebo (67.7% vs 29.7%, respectively). Furthermore, there was also a significant difference in the QMC responder rate for the first treatment cycle at 63.1% and 14.1%, respectively.3
In the other study (NCT04281472), investigators divided it into 2 parts. In part A, 322 patients received up to 12 once weekly subcutaneous injections. Of those, 221 patients entered part B, where patients received once weekly subcutaneous injections of the drug. Investigators found patients who received the study drug had a longer time to clinical deterioration compared with patients receiving the placebo.3
“The daily burden of CIDP from both the symptoms of the disease and interruption to daily life creates profound unseen challenges for patients,” Lisa Butler, executive director at the GBS-CIDP Foundation, said in a news release.1 “Effective new treatments that reduce the need for frequent clinic visits are a welcome option for active patients seeking to regain time and a sense of normalcy in their daily routine. Today’s news about the approval of argenx’s prefilled syringe for at-home self-injection is a significant step forward for those patients seeking a new treatment option.”
READ MORE: Neurology Resource Center
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