Close
Close
Treatment News

FDA Grants Priority Review for Genentech’s Rituxan (Rituximab) for Pemphigus Vulgaris

3.16666666667
3.2 from 6 votes
Wednesday, February 14, 2018

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of Rituxan (rituximab) for the treatment of pemphigus vulgaris (PV), a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV. Presently, there are limited approved treatment options available for patients with PV.

"We are committed to developing medicines for rare diseases with limited treatment options, such as pemphigus vulgaris," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We look forward to continued work with the FDA to hopefully provide patients with a new treatment for this serious and potentially life-threatening disease."

The sBLA submission is based on data from a Roche-supported randomized trial conducted in France which evaluated Rituxan plus a tapering regimen of low dose oral corticosteroid (CS) treatment compared to a standard dose of CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. Results of the study show that Rituxan provides substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy. These results were published in The Lancet in March 2017. Genentech is currently conducting another Phase III study in PV which is evaluating Rituxan plus a tapering regimen of CS compared to Cellcept (PEMPHIX, NCT02383589).3

About Pemphigus Vulgaris
Pemphigus vulgaris is an autoimmune, intraepidermal, blistering disease affecting the skin and mucous membranes. This rare, life-threatening condition is the most common type of a group of autoimmune disorders collectively called pemphigus, which affect 30,000 to 40,000 people in the United States.

What does Rituxan treat?
Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.

Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.

People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or effective in children.

About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

Contacts:
Genentech
1 DNA Way
South San Francisco, CA 94080

Corporate Headquarters, South San Francisco, CA
Phone: (650) 225-1000
            (800) 626-3553
Fax: (650) 225-6000 Fax

Source: Genentech, Inc.
3.16666666667
3.2 from 6 votes
Free Newsletter
Related Videos
by Abidemi Uruejoma
522 views
by Abidemi Uruejoma
522 views
by Abidemi Uruejoma
5,869 views
by Abidemi Uruejoma
5,869 views