New Indication Approved for Rituxan
June 7, 2018 – The U.S. FDA has approved a new indication for Rituxan® (rituximab), manufactured by Genentech. It is now approved to treat moderate-to-severe pemphigus vulgaris (PV) in adult patients. Rituxan is the first biologic approved for PV.
Approval for the new indication was based on clinical studies in which 90% of patients who received Rituxan achieved complete remission after 24 months of treatment, versus 28% of patients who were treated only with a corticosteroid. Recommended initial dosing under the new indication is two 1000mg intravenous (IV) infusions given two weeks apart. Patients should also receive a tapering course of glucocorticoids. Twelve months after beginning treatment, patients should be administered a 500mg IV infusion of Rituxan. This dose should be repeated every six months, based on clinical evaluation.
A rare autoimmune disorder, PV leads to painful blistering of the skin and mucous membranes. Mortality rates were high prior to the use of modern treatments, which include corticosteroids. With treatment, PV is fatal in approximately 5% of cases, often due to complications such as systemic infection.
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.