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SOURCE Medac Pharma, Inc.
U.S. District Court for the District of Delaware Concurrently Denies Motion For Preliminary Injunction Filed by Antares Pharma, Inc.
CHICAGO, July 14, 2014 /PRNewswire/ -- Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that the U.S. Food and Drug Administration (FDA) has approved Rasuvo™, a subcutaneous injectable methotrexate (MTX) therapy delivered in an auto-injector for rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA) and psoriasis. Rasuvo will be available in 10 dosage strengths, ranging from 7.5 mg to 30 mg in 2.5 mg increments and will be launched in the U.S.
The company concurrently announced that the U.S. District Court for the District of Delaware has denied a motion for a preliminary injunction filed by Antares Pharma, Inc.
"We're delighted to have secured approval for our lead product, Rasuvo, and look forward to introducing this much-needed therapy to the market," stated Ms. Terri Shoemaker, President and CEO of Medac Pharma, Inc. "Methotrexate has long been recognized as a mainstay in rheumatoid arthritis therapy. With its virtually painless administration, broad dose range, and significantly enhanced bioavailability, we believe Rasuvo may benefit those patients using methotrexate." Regarding the U.S. District Court for the District of Delaware's decision, Ms. Shoemaker stated, "We're pleased with the Court's decision and are moving forward with our commercialization efforts as planned."
With more than 30 years of clinical usage, MTX remains the most commonly used drug for treating RA and is recommended by both the American College of Rheumatology and European League Against Rheumatism as a first-line therapy for RA patients. While many patients prescribed MTX take an oral form of this drug, this route of administration has been associated with highly variable absorption rates and inconsistent bioavailability among patients.
Medac Pharma, Inc. developed Rasuvo to optimize MTX therapy. The subcutaneous mode of delivery of Rasuvo, with its wide range of dosing options, has been designed to improve bioavailability.
Rheumatologist Eric Ruderman, MD, Professor of Medicine, Northwestern University Feinberg School of Medicine, stated, "As a rheumatologist, I believe Rasuvo will offer patients the opportunity to maximize the benefit they get from methotrexate. Rasuvo's dosing flexibility, in particular, will be very helpful, as RA patients do not all respond equally to methotrexate, making it important to select a treatment regimen that is appropriate for the patient's condition."
For complete prescribing information, including Boxed Warning, please visit www.Rasuvo.com.
Indications and Important Safety Information Including Boxed Warning
Rasuvo is a folate analog metabolic inhibitor indicated for the:
Limitations of Use
Rasuvo is not indicated for treatment of neoplastic diseases.
This product includes the following Black Box Warning:
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND DEATH
Rasuvo should be used only by physicians whose knowledge and experience include the use of antimetabolite therapy. Because of the possibility of serious toxic reactions (which can be fatal), Rasuvo should be used only in patients with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy. Deaths have been reported with the use of methotrexate in the treatment of malignancy, psoriasis, and rheumatoid arthritis. Patients should be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities. Patients should be informed by their physician of the risks involved and be under a physician's care throughout therapy.
Rasuvo is contraindicated in the following:
WARNINGS AND PRECAUTIONS
The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse reactions are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection.
USE IN SPECIFIC POPULATIONS
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Medac Pharma, Inc.
Medac Pharma, Inc. is the wholly-owned subsidiary of medac GmbH, a well-known and respected global pharmaceutical company that has been making scientific and therapeutic discoveries for more than 40 years.
Medac Pharma, Inc. is focused on developing therapies with the potential to make meaningful differences in patients' lives. The company's approach is to improve existing agents by enhancing the mode of delivery, addressing safety profiles and inventing ways to maximize efficacy.
For more information, please visit www.medacpharma.com.
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