FDA approves new treatment for myasthenia gravis

Press release

SILVER SPRING, Maryland, December 17, 2021

Approval is the first in a new class of drugs for this rare, chronic, autoimmune neuromuscular disease

SPRING SILVER, Md., December 17, 2021 / PRNewswire / – The United States Food and Drug Administration today approved Vyvgart (efgartigimod) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor antibody (AChR).

Myasthenia gravis is a chronic autoimmune neuromuscular disease that causes weakness in skeletal muscles (also called voluntary muscles) that worsens after periods of activity and improves after periods of rest. Myasthenia gravis affects voluntary muscles, especially those responsible for controlling the eyes, face, mouth, throat, and limbs. In myasthenia gravis, the immune system produces AChR antibodies which interfere with communication between nerves and muscles, resulting in weakness. Severe attacks of weakness can cause breathing and swallowing problems that can be life threatening.

“There are significant unmet medical needs for people with myasthenia gravis, as with many other rare diseases,” said Billy Dunn, MD, director of the Office of Neuroscience at the Center for Drug Evaluation and Research, FDA. “Today’s approval is an important milestone in delivering a new treatment option to patients and underscores the agency’s commitment to help make new treatment options available to people living with illnesses. rare. “

Vyvgart is the first approval of a new class of drugs. This is a fragment of an antibody that binds to the neonatal Fc receptor (FcRn), preventing the FcRn from recycling immunoglobulin G (IgG) in the blood. The drug causes a reduction in overall IgG levels, including the abnormal AChR antibodies that are present in myasthenia gravis.

The safety and efficacy of Vyvgart was evaluated over a 26 week period clinical study of 167 patients with myasthenia gravis who were randomized to receive Vyvgart or placebo. The study showed that a greater number of myasthenia gravis patients with antibodies responded to treatment during the first cycle of Vyvgart (68%) compared to those who received a placebo (30%) over a period of time. measure that assesses the impact of myasthenia gravis on daily function. More patients receiving Vyvgart also demonstrated a response on a measure of muscle weakness compared to placebo.

The most common side effects associated with the use of Vyvgart include respiratory tract infections, headaches, and urinary tract infections. Because Vyvgart causes a reduction in IgG levels, the risk of infections may increase. Hypersensitivity reactions such as swelling of the eyelids, shortness of breath and rash have occurred. In the event of a hypersensitivity reaction, interrupt the infusion and institute appropriate treatment. Patients using Vyvgart should watch for signs and symptoms of infections during treatment. Healthcare professionals should administer appropriate therapy and consider delaying administration of Vyvgart to patients with active infection until the infection resolves.

The FDA granted this request Expressway and Orphan drug designations. The FDA has granted Vyvgart approval to argenx BV.

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Media contact: Courtney rhodes, 202-281-5237
Consumer inquiries: Email or 888-INFO-FDA

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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SOURCE US Food and Drug Administration


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