Summary
The FDA approved Stelara based on three studies of 2,266 patients who either got shots of Stelara or a placebo. Patients who got Stelara were more likely to achieve the studies' benchmark for reduction in psoriasis.
In a news release, the FDA notes that because Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. "Serious infections have been reported in patients receiving the product and some of them have led to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer," the FDA states.
Analysis
This is a drug whose approval has been pending for a while. There is certainly a need, especially given the removal of efalizumab from the market. This drug has many positive points, including infrequent dosing and outstanding efficacy. The limitation of the drug is a lack of long-term safety data. Initial uptake should be rapid because many patients who failed TNF-inhibitors have been awaiting this drug. The FDA is requiring a risk evaluation and mitigation strategy for Stelara that includes a communication plan targeted to health care providers and a medication guide for patients.
Jeffrey Weinberg consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
