Rystiggo, a medication for generalized myasthenia gravis, received its initial approval from the U.S. Food and Drug Administration (FDA) on June 20, 2023 [1].
When does Rystiggo's exclusivity expire?
DrugPatentWatch.com tracks patent expirations and regulatory exclusivities for medications like Rystiggo. Information regarding the specific duration of Rystiggo's market exclusivity, which can be distinct from patent expiry, is available through services that monitor these details [2].
What is Rystiggo used for?
Rystiggo is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive [1]. gMG is a chronic autoimmune neuromuscular disease that causes weakness in the voluntary muscles [3].
How does Rystiggo work?
Rystiggo is a neonatal Fc receptor (FcRn) blocker. By blocking the FcRn, it reduces the levels of immunoglobulin G (IgG) antibodies, including pathogenic autoantibodies that contribute to gMG [1].
What are the side effects of Rystiggo?
Common side effects reported for Rystiggo include muscle pain, headache, diarrhea, rash, and COVID-19 [1]. Patients experiencing side effects should consult their healthcare provider [4].
What are the regulatory approvals for Rystiggo in other regions?
Following its U.S. approval, Rystiggo also received approval from the European Medicines Agency (EMA) on July 25, 2023 [5].
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Sources:
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217301s000lbl.pdf
2. https://drugpatentwatch.com/
3. https://www.mayoclinic.org/diseases-conditions/myasthenia-gravis/symptoms-causes/syc-20352172
4. https://www.rymylan.com/assets/pdf/Rystiggo%20Prescribing%20Information.pdf
5. https://www.ema.europa.eu/en/medicines/human/EPAR/rystiggo