Genentech, a member of the Roche Group, announced, Jan. 23, that the FDA has approved the company's Supplemental Biologics License Application for Actemra. The medication will be employed for the treatment of giant cell arteritis (GCA), a potentially life-threatening autoimmune condition.
The FDA has also granted Priority Review Designation for the medication, based on the positive results of the Phase III GiACTA study, which evaluated the medicine in people with the autoimmune condition it treats.
GCA Treatment Actemra, FDA Approved
The results of the Phase III trial showed that Actemra, initially mixed with a six-month steroid regimen, was more efficient in sustaining remission through an entire year compared to six-month or 12-month steroid regimen alone administered to patients who suffer from GCA.
"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," noted Sandra Horning, M.D., chief medical officer and head of Global Product Development.
GCA is a disease of blood vessels, and it can happen along with polymyalgia rheumatica. Approximately 10 to 15 percent of the people with PMR also have GCA, while almost 40 percent of the people who suffer from GCA also have PMR, according to the University of Oklahoma Health Sciences Center.
Actemra has serious side effects. The treatment modifies the mechanism of the body's immune system, making the patients less powerful in fighting infections. There were also some people who followed the treatment and died because of their weak immune system. Among other serious side effects, stomach tears, changes in blood results and an increased risk of getting certain cancers or a hepatitis B infection are the most prevalent.
Concerning the pregnant patients — or the ones who are currently breastfeeding or plan to have children — the doctors should be well-informed about these life decisions, as they are the only ones who can decide whether or not the Actemra treatment is safe for the future mother. This decision is made individually, for each patient.
GCA, A Disease Of The Elderly
GCA usually affects older adults, especially those above the age of 50, and it typically consists of the swelling and thickening of the small artery under the skin, called the temporal artery.
One of the most common symptoms announcing GCA is a new, persisting headache. Should the illness affect the blood flow to the eye, loss of vision can also occur. However, a prompt diagnosis of the disease can be helpful in preventing this type of extreme consequence.
The CGA diagnosis cannot be emitted after just one simple procedure, such as a blood test or other non-invasive way. Instead, a biopsy can be conducted on a piece of the temporal artery. Once the piece is removed, it will be subjected to outpatient analysis and studied under a microscope for signs of inflammation.
"Giant cell arteritis can be difficult to diagnose and requires prompt treatment to preserve vision. Rheumatologists are specialists in inflammatory diseases of blood vessels, and thus are experienced in the diagnosis and management of these unusual disorders," notes a fact sheet on the disease.
