On Tuesday, the United States Food and Drug Administration (FDA) has accepted the Supplemental Biologics License Application from the Roche Group’s Genentech for priority review designation for a new rheumatoid arthritis drug Actemra (tocilizumab) for the purpose of treating giant cell arteritis (GCA).
GCA is a chronic autoimmune condition caused by inflammation of large- and medium-sized arteries. It most often seems to afflict arteries of the head but has also been found to affect those in the aorta (and its branches). The condition can be life-threatening, so a treatment is certainly hopeful.
Indeed, Genentech chief medical officer and head of Global Product Development, Sandra Horning, notes, “This positive outcome in GCA, a condition for which there have been no new treatments in more than 50 years, demonstrates Genentech’s commitment to helping patients with unmet needs.” As such, she adds, “We are pleased by the FDA’s decision to classify their review of the sBLA as priority. We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible.”
The FDA grants Priority Review Designation to medicines that the agency has determined to possess great potential for providing significant improvements in safety and effectiveness in the treatment of any serious disease.
The granting of this Priority Review Designation, of course, comes on the heels of Genentech’s October 2016 receipt of Breakthrough Therapy Designation for the same medication. A breakthrough designation is intended to help speed along the development and necessary review of any medicine which has shown, early on, substantial clinical benefits in the treatment of serious diseases and in order to help ensure patients can receive access to these medicines as soon as possible.
This approval is important because Actemra can have serious side effects. This might include:
• stomach tearing
• Hepatitis B infection
• problems with the nervous system
• increased risk for developing certain cancers (because the drug can affect the operation of the immune system)
• serious allergic reaction (potentially fatal)
Rheumatoid arthritis patients treated with Actemra may also experience:
• upper respiratory tract infections
• injection site reaction