Roche's Actemra Granted Priority Review By FDA
Roche's rheumatoid arthritis medication Actemra was granted priority review by the U.S. Food and Drug Administration (FDA) on Tuesday. FDA also approved the company's Supplemental Biologics License Application.
Genentech, member of the Roche Group that conducted the study, is determined to continue to work closely with FDA to make Actemra safe and available to people with giant cell arteritis (GCA).
According to Reuters, giant cell arteritis is caused by an inflammation of large and medium-sized arteries. It can be often found in the head and also in the aorta and its branches. It is considered to be a chronic life-threatening autoimmune condition.
According to the University of Oklahoma Health Sciences Center GCA is a disease of blood vessels and usually goes along with polymyalgia rheumatica (PMR). Around 15 percent of people with PMR have been found to have GCA, and around 40 percent of people with GCA also have PMR.
GCA usually affects people aged 50 and above. Symptoms include swelling, thickening or temporal artery and head ache.
If it affects the blood flow to the eye, elders may suffer loss of vision if not treated immediately. It is difficult to diagnose as it requires a biopsy of the temporal artery and further analysis to determine if there is inflammation.
Tech Times reported Phase III of the GiACTA study showed positive results for the use of Actemra. It was mixed with a steroid regimen for six months and was found to be more efficient in sustaining remission for patients with GCA.
However, Actemra was found to lower the immune system, cause stomach tears, changes in blood results and increased risk of getting cancer or hepatitis B are a few of its serious side effects. This is why FDA granted the priority review, to ensure that the product can be safe for patients with GCA.