New Indication for Soliris
October 23, 2017 – The U.S. FDA has approved a new indication for Soliris® (eculizumab), manufactured by Alexion Pharmaceuticals, to treat certain patients with generalized myasthenia gravis (gMG).
An autoimmune disease that causes progressive muscle weakness, myasthenia gravis (MG) is believed to affect approximately 60,000 people in the United States. Symptoms include difficulty speaking or swallowing, as well as double vision. In women, these symptoms typically become apparent before 40 years of age, while men often do not show signs of MG until after age 60. The effects of MG worsen over time, and can lead to fatigue, loss of movement, and difficulty breathing.
MG is caused when abnormal proteins interfere with the correct function of acetylcholine, a neurotransmitter responsible for making muscles contract. To be eligible for treatment with Soliris, patients must test positive for anti-acetylcholine receptor (AchR) antibodies. An estimated five to ten percent of patients with gMG meet these criteria. Recommended dosing is 900mg once per week for four weeks, then 1,200mg in the fifth week, followed by 1,200mg every two weeks thereafter.
Soliris also holds FDA approval for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). For all indications, Soliris must be given by specially trained and certified medical professionals as part of a risk evaluation and mitigation strategy (REMS). The drug carries a black box warning cautioning patients that its use has been linked to severe meningococcal infections. The current list price for Soliris is approximately $7,200 per 300mg vial.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.