(By Balaseshan) Antares Pharma Inc. (NASDAQ: ATRS) shares jumped 7.42% in premarket after the U.S. Food and Drug Administration (FDA) has accepted its new drug application for treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
The FDA indicated that the application is sufficiently complete to permit a substantive review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 14, ten months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.
Otrexup is a potential new product for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet technology. Otrexup is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
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Studies conducted to date indicate Otrexup is safe, easy and comfortable for RA patients to self-administer precise subcutaneous doses of MTX with improved systemic availability compared to oral doses.
Rheumatoid Arthritis is a form of inflammatory arthritis and an autoimmune disease. In rheumatoid arthritis, the immune system – which is designed to protect health by attacking foreign cells such as viruses and bacteria – instead attacks the body's own tissues, specifically the synovium, a thin membrane that lines the joints.
Psoriasis is a chronic, autoimmune disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is not contagious. According to the National Psoriasis Foundation, as many as 7.5 million Americans have psoriasis.
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ATRS closed Tuesday's regular session up 0.30% at $3.37. The stock has been trading between $2.51 and $5.58 for the past 52 weeks.