PhRMA highlights industry's autoimmune drug pipeline
- PhRMA reports there are over 300 potential new drugs in the R&D pipeline, targeting diseases from arthritis to type 1 diabetes.
- The autoimmune diseases market could be worth $52 billion by 2022, according to Credence Research.
- Autoimmune diseases affect over 23.5 million people in the US and many more worldwide; many have few treatment options and no chance of cure.
More than 80 autoimmune diseases have been identified, but many, such as lupus, have few treatment options. The biopharma industry has spotted this gap in the market and is rushing to fill it – there are currently 311 drugs and vaccines in in clinical trials or awaiting FDA approval, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA).
The most active areas of development are autoimmune arthritis and inflammatory bowel disease, which together make up over 40% of the pipeline. Treatments for rheumatoid arthritis and other forms of arthritis have previously treated symptoms without affecting the course of the disease. New and innovative disease-modifying anti-rheumatic drugs are targeting the underlying inflammation, potentially halting or even reversing joint damage.
The advent of the anti-TNF antibodies changed the face of rheumatoid arthritis treatment, although they have been linked with potentially serious infections. The newer JAK inhibitors, such as Pfizer’s Xeljanz (tofacitinib) have been another breakthrough, but are also associated with serious infections, lymphoma and cancers. The opportunity for the new drugs in development, including Eli Lilly and Incyte’s JAK1/JAK2 inhibitor, baricitinib, will be to deliver the efficacy with better safety.
Another active area of research is systemic lupus erythematosus. There have been no drugs approved for lupus in the past 60 years, but there are now almost 40 in the pipeline. These include AstraZeneca’s monoclonal antibody anifrolumab, which is in Phase 2 development and has forecasted sales of over $1 billion. However, there are always going to be challenges along the way. Aurinia Pharmaceuticals has seen patient deaths in its Phase 2b study of voclosporin in lupus kidney disease. This led to a stock market stumble that overshadowed the positive data, although the fatalities may be as a result of disease severity rather than study treatment.
Follow Suzanne Elvidge on Twitter