Is Vyvgart Hytrulo approved by the FDA?
Vyvgart Hytrulo received FDA approval on June 20, 2023. It is approved for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The approval was later expanded to include adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
What is Vyvgart Hytrulo?
Vyvgart Hytrulo is a combination drug consisting of efgartigimod alfa and hyaluronidase. It is used to treat generalized myasthenia gravis (gMG) to improve muscle strength and chronic inflammatory demyelinating polyneuropathy (CIDP) to slow symptom deterioration in adults.
How does Vyvgart Hytrulo work?
Vyvgart Hytrulo works by targeting and blocking the neonatal Fc receptor (FcRn), a protein involved in regulating levels of autoantibodies. In gMG, autoantibodies attack acetylcholine receptors, leading to muscle weakness. Efgartigimod alfa reduces these autoantibodies, while hyaluronidase increases tissue permeability, allowing for subcutaneous administration.
Dosage and Administration:
- Generalized myasthenia gravis (gMG): The recommended dosage is 1,008 mg/11,200 units (efgartigimod alfa and hyaluronidase), administered as 4 weekly subcutaneous injections per treatment cycle.
- Chronic inflammatory demyelinating polyneuropathy (CIDP): The recommended dosage is the same as for gMG, with weekly subcutaneous injections.
Side Effects:
Common side effects include:
- Respiratory tract infections
- Headache
- Urinary tract infections
- Injection site reactions
Serious side effects may include:
- Signs of infection (fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising, or bleeding)
- Allergic reactions (hives, difficulty breathing, swelling of face, lips, tongue, or throat)
Warnings and Precautions:
- Infection Risk: Vyvgart Hytrulo can increase the risk of infections. Do not administer if the patient currently has an infection.
- Hypersensitivity Reactions: Monitor for signs of hypersensitivity reactions during and after administration.
- Vaccinations: Live or live-attenuated vaccines should not be administered during treatment.
Storage:
Store vials of Vyvgart Hytrulo in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake. Unopened vials may be kept at room temperature (20°C to 25°C or 68°F to 77°F) for up to 3 days before administration.
Vyvgart Hytrulo represents an important advancement in the treatment of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, offering a targeted approach to reduce autoantibodies and improve patient outcomes.
How to obtain the latest development progress of all drugs?
In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!
