FDA Assigns Priority Review Designation to Genelabs Aslera(TM) for Lupus
<<<REDWOOD CITY, Calif., Oct. 25 /PRNewswire/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB) announced today that the United States Food and Drug Administration (FDA) has granted the company's Aslera(TM) New Drug Application (NDA) priority review designation. Aslera(TM) (GL701 or prasterone) is Genelabs' investigational drug for treatment of the chronic autoimmune disease systemic lupus erythematosus (SLE or lupus).
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Priority review designation is granted by the FDA to products that are considered to be a potential therapeutic advance over current treatments and generally provides for a six-month review period, beginning with the date of the NDA submission. Genelabs completed the Aslera(TM) NDA submission on September 26, 2000. The company is seeking approval of Aslera(TM) as a new treatment for women with mild to moderate SLE.
"We are gratified that the FDA responded so promptly in designating priority review for the Aslera(TM) NDA, in recognition of the current lack of adequate treatments for women with SLE," said James A.D. Smith, President and Chief Executive Officer of Genelabs. "Given the rapid review provision for products with priority review status, the company is aggressively moving forward with our commercialization plans for Aslera(TM)."
Marc Gurwith, M.D., Genelabs Vice President, Drug Development and Chief Medical Officer, commented, "There is a great need for new medications for patients who suffer from the many different signs and symptoms of lupus. The current therapies for SLE patients are limited and often associated with significant toxicities. Our Aslera(TM) NDA is supported by data from two double blind, placebo-controlled, multicenter Phase III clinical trials which showed the ability of Aslera(TM) to improve SLE disease and reduce steroid requirements in women with lupus. The side effects associated with Aslera(TM) in these trials were generally mild. Aslera(TM) has the potential to become the first new lupus therapy approved by the FDA in 40 years."
SLE primarily affects women, many of whom experience the initial onset of disease in their late teens and early twenties. Approximately 200,000 people in the United States and more than one million worldwide have lupus, according to U.S. government and private sector statistics. Lupus causes the immune system to attack the body's own tissue, which can lead to inflammation, arthritis pain, tissue injury and major organ damage. Common signs and symptoms of the disease that lupus sufferers experience -- extreme fatigue, arthritis, fever, seizures, headache, muscle weakness, memory loss, hair loss, facial rash, photosensitivity and depression -- can lead to poor quality of life. More serious, life-threatening symptoms include inflammation of the lungs, heart and brain tissue and organ damage, most often involving the kidneys.
Previously the FDA granted Fast Track designation to Aslera(TM) for SLE, which means that the FDA has determined that Aslera(TM) is intended to treat a serious or life-threatening condition for which there is no adequate therapy currently available. In 1994, GL701 received Orphan Drug designation from the FDA for the treatment of SLE. Orphan Drug designation provides for up to seven years of marketing exclusivity from the date of a drug's approval.
Note: Except for historical information, the statements in this news release are forward-looking and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, whether the results of the company's clinical trials of Aslera(TM) and other supporting information will be sufficient to support the approval of Aslera(TM) by FDA; delays regarding the regulatory approval process including the timing and scope of approval received, if any; uncertainties and risks regarding market acceptance of Aslera(TM) as a treatment for SLE; the company's limited manufacturing and marketing experience; the validity, scope and enforceability of patents related to Aslera(TM); the company's capital requirements and history of operating losses; and uncertainties and risks regarding the company's ability to raise needed additional capital or consummate strategic or corporate partner transactions on favorable terms or at all. The active ingredient in Aslera(TM) is prasterone, the synthetic equivalent of the androgenic hormone dehydroepiandrosterone (DHEA). Products containing DHEA are currently being marketed by others as dietary supplements. The company has not submitted applications for regulatory review outside the US. In addition, neither U.S. nor foreign regulatory authorities have made a determination as to the safety or efficacy of Aslera(TM) for SLE. Please see the information appearing in the company's filings with the Securities and Exchange Commission for more discussion regarding these uncertainties and risks and those associated with the company's research programs, early stage of development and other risks which may affect the company. The company does not undertake any obligation to update these forward-looking statements to reflect events or circumstances after the date of this release.
Genelabs' press releases are available by fax 24 hours a day at no charge by calling PR Newswire's Company News On-Call at 800-758-5804, extension 115-419. They are also posted on the Internet at genelabs.com and prnewswire.com .
SOURCE Genelabs Technologies, Inc.
CO: Genelabs Technologies, Inc.; United States Food and Drug Administration
ST: California
IN: MTC BIO
SU:
10/25/2000 08:03 EDT prnewswire.com>>> |
