Febuxostat recommended by panel for treatment of hyperuricemia in patients with gout
Today, the average size soft drink is 20 ounces and contains 17 teaspoons of sugar. More startling is that some citric acids found in fruit drinks are more erosive than hydrochloric or sulfuric acid - which is also known as battery acid. These refined sugars and acids found in soda and citrus juice promote tooth
Full Post: Drink tea instead of soft drinks to avoid tooth erosion
Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout.
The vote was 12 to zero in favor of approval, with one panel member abstaining. The vote followed presentations by Takeda Global Research & Development Center, Inc., the FDA, and invited guest speakers. If approved in the United States by the FDA, febuxostat will be the first new treatment for the management of hyperuricemia associated with gout in more than 40 years.
The FDA will review the current new drug application for febuxostat and make its approval decision. The FDA’s decision may or may not follow the Committee’s recommendation.
“Today’s vote by the Arthritis Advisory Committee, recommending approval of febuxostat for the treatment of hyperuricemia in patients with gout, is a positive step in bringing this new treatment to market,” said Nancy Joseph-Ridge, MD, president, Takeda Global Research & Development, Inc., U.S. “Takeda is committed to developing innovative therapies that fulfill unmet treatment needs, and we believe febuxostat will represent an important new option for patients who suffer the debilitating effects of gout. In the coming months, we will work with the FDA to complete their review, including the design of post-marketing studies.”
Febuxostat is a potent non-purine, selective inhibitor of xanthine oxidase, which was studied for its ability to lower levels of serum uric acid in patients with hyperuricemia associated with gout. Hyperuricemia, elevated uric acid levels in the body, is associated with gout, a painful type of arthritis. In clinical trials, febuxostat 40 mg and 80 mg were shown to be effective treatments for the management of hyperuricemia associated with gout. Both doses were well tolerated and required no dose adjustments in patients with renal impairment. The most commonly reported adverse events were upper respiratory tract infections, musculoskeletal and connective tissue signs and symptoms, and diarrhea.
Uric acid is an end-product created when the body breaks down naturally occurring substances called purines. Hyperuricemia occurs when this process results in elevated uric acid levels, either through overproduction or underexcretion of uric acid or a combination of the two. Hyperuricemia is a precursor to gout; the higher a person’s urate level, the greater the risk for developing gout.
Gout is the most common inflammatory arthritis in men over age 40. According to the National Health and Nutrition Examination Survey III 1988-1994, an estimated 5.1 million Americans suffer from gout. It is a chronic condition characterized by attacks, or “flares,” marked by intense pain, redness, swelling, and heat in the affected joint. These symptoms are the result of an acute inflammatory response to the presence of crystallized uric acid in the joint(s). As the disease progresses, these attacks may become more frequent and patients may develop large deposits of crystallized uric acid visible under the skin, known as tophi, that can eventually lead to complications including pain, soft tissue damage and deformity, as well as joint destruction and nerve compression syndromes such as carpal tunnel syndrome.
Researchers in the U.S. say a new drug effectively treats serious cases of gout - the drug called pegloticase mimics a blood-clearing enzyme missing in humans and helps remove the build up in uric acid, which causes the painful, needle-like crystals to collect around fingers, toes and other joints. Pegloticase made by the Savient
Full Post: New gout drug offers hope for those who have exhausted treatment options
Savient Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s Biologics License Application (BLA) for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted the Company’s BLA with a priority review status which accelerates the review period to six months. A
Full Post: Pegloticase BLA filing accepted for priority review by FDA
Sanofi-aventis has announced results of a randomized phase III study presented at the 50th Annual Meeting of the American Society of Hematology. The study in adult patients with hematological malignancies at high or potential risk for tumor lysis syndrome (TLS) demonstrated that Elitek(R) (rasburicase) significantly reduced plasma uric acid (PUA) levels compared to allopurinol
Full Post: Trial shows Elitek significantly reduces plasma uric acid levels versus Allopurinol in adults with hematologic cancers at risk for tumor Lysis syndrome
The U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee today voted unanimously to recommend approval of Bausch & Lomb’s besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis. The company has developed this broad-spectrum, anti-infective drop specifically for ophthalmic use. All new chemical entities such as besifloxacin, a fluoroquinolone, must
Full Post: FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop
Amgen and Millennium: The Takeda Oncology Company, a subsidiary of Takeda Pharmaceutical Company Limited , today announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been temporarily suspended following a planned safety data
Full Post: Amgen, Takeda and Millennium update on phase 3 trial of Motesanib in non-small cell lung cancer