Leading the way to a cure

Lupus Research Update: 2010 Volume 1

Volume 1, 2010 - Online Edition | In This Issue

The Expanding Horizons of Lupus Research >
A Message from the President >
Turning Promising Ideas Into Effective Treatments >
New Drug Shows Positive Results In Clinical Trial >
ALR Announces 2010 TIL Grantees >
Lupus News Corner >

Turning Promising Ideas Into Effective Treatments

The drug approval process is long, laborious and often frustrating — but the prospect of finding a treatment or cure for a disease like lupus is certainly worth every effort.

And as the below graph illustrates, it can take a decade — or longer — to develop a new drug from laboratory concept to pharmacy shelf. The search for solutions begins with pilot experiments that can involve potentially thousands of compounds. Most of these compounds will be eliminated — leaving only a handful that may be considered viable candidates for further study.

Next, studies are conducted to determine whether the potential new drug provides a real health benefit — and if it is safe. An application must be made to the U.S. Food and Drug Administration (FDA) — before it can be tested in humans. The entire drug approval process can cost hundreds of millions of dollars, and follows a series of phases:

  • Phase I: Clinical studies in this phase represent the first time that an Investigational New Drug is tested on either healthy volunteers or patients – with the aim to determine safety and dosage. Studies are usually conducted on 20 to 100 subjects.
  • Phase II: Trials are expanded to involve hundreds of patients to evaluate effectiveness and side effects.
  • Phase III: These longer clinical trials verify the effectiveness and allow scientists to extrapolate the results to the general population. Thousands of patients/volunteers are involved.

Since the ALR was founded ten years ago, much more is known about the nature of lupus and many keenly awaited potential new drugs are now in the pharmaceutical pipeline. Two examples are Benlysta, which we discussed in the last issue of our newsletter and Epratuzumab, which you can read about on page three.

Drug Development Pipeline: From the Lab to People with Lupus
(click image to enlarge)

1.5 million

people in the U.S. have Lupus.

172 million

dollars committed to lupus research by the Lupus Research Alliance.

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