Posts for tag: FDA
FDA approved Valeant's Siliq to treat adults with moderate-to-severe plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales, is the most common form of the disease.
A patient's body coverage is measured and if above 10% the biologic prescription is processed for approval with our on-site coordinator, Sue Lamb. One needs to be checked and cleared for TB with our on-site test and return three days later for a reading to identify a smooth surface by our medical staff. A before and after picture will be taken and any marking beyond clear will require the provider to be notiified for final measurement of area before a biologic can be administered.
Siliq is noted to be forewarned of suicidal behavior by the FDA labeling. All IDT psoriasis patients' are placed in prescription program and monitored to provide top-notch safety, alongside a 3-month evaluation with Dr. Schreiber.
According to the American Academy of Dermatology, rates of melanoma have been increasing for the past 30 years. By 2015, it is estimated that 1 in 50 Americans will develop melanoma in their lifetime. Recently, the Food and Drug Administration (FDA) has granted accelerated approval to pembrolizumab (Keytruda) for the treatment of melanoma unable to be surgically removed, reports the Dermatology Times. Keytruda is the sixth new melanoma treatment approved since 2011. Preliminary clinical evidence suggests that Keytruda is an improvement over current drugs targeting melanoma. Keytruda is the first melanoma drug to block a cellular pathway known at PD-1, allowing the immune system to attack cancerous cells. While the preliminary results are encouraging, more research must be done to determine if Keytruda enhances the survival rate of patients with advanced melanoma.
According to an article in HealthDay, the US Food and Drug Administration reports that our greater understanding of Psoriasis has led to more patient-specific treatment options. Doctors and patients now have a wide variety of factors to consider, including effectiveness, severity of the disease, lifestyle, and other risk factors. Because there is no cure for psoriasis, the primary goal of therapy is to reduce inflammation and stop skin cell overproduction. Doctors tweak their therapies through a step-by-step approach, typically starting with topical therapy for mild cases of psoriasis and moving onto stronger phototherapy or drug treatment for more severe cases. According to FDA dermatologist Dr. Melinda McCord, “Tomorrow's treatments will become even more personalized because the drugs in development now are targeting different aspects of the immune system.”