Lupus drug Benlysta has been approved by the Food and Drug Administration, becoming the first new lupus drug approved in 56 years.
The intravenous drug was developed by Maryland-based Human Genome Sciences (NASDAQ:HGSI) and GlaxoSmithKline (NYSE:GSK), the British pharmaceutical giant which maintains its American headquarters in Research Triangle Park, North Carolina.
Lupus is an autoimmune disease, affecting primarily women, in which the body attacks healthy tissues. Benlysta works by inhibiting a protein, in turn reducing the number of abnormal cells thought to be a problem in lupus.
Benlysta has been in development for more than 15 years. Discovered by HGS in 1996, the company entered into a co-development and commercialization agreement with GSK 10 years later. Some industry observers have said the drug could become a blockbuster.
But tests show that the drug doesn’t work on everyone. In two clinical studies, African American patients and patients of African heritage did not appear to respond to treatment with the drug. No definitive conclusion was reached and to address this concern. HGS and GSK will conduct additional studies.
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A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
