FDA approves treatment for fat below the chin Source: FDA April 29, 2015 The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended. Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin."Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment," said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area." Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds. The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat. Participants were randomly assigned to receive Kybella or a placebo for up to six treatments. The results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo. Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area. Kybella should not be used outside of the submental area, and it should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area. Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, do not use the product. Consumers and health care professionals are encouraged to report adverse reactions from the use of Kybella to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-FDA-1088. Kybella is manufactured by Kythera Biopharmaceuticals Inc. based in Westlake Village, California. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
KYTHERA Biopharmaceuticals Announces US Availability of KYBELLA™ – First FDA-Approved Injectable Treatment for "Double Chin" – Through KYBELLA™ Trained Physicians June 19, 2015 Westlake Village, Calif., June 19, 2015 — KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced the U.S. availability of KYBELLA™ (deoxycholic acid) injection, the first and only FDA-approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition also known as "double chin." KYBELLA™ was approved in April by the U.S. Food and Drug Administration (FDA), and can now be purchased by physicians who have been trained on the safe use of KYBELLA™ and its approved indication. Training began earlier this month for KYBELLA™ physician trainers, with broader KYBELLA™ physician training programs to begin in late summer. Only physicians who have participated in a training program will be able to purchase KYBELLA™ and treat patients. KYBELLA™ will be available to trained physicians in a pack of four, 2 mL, single-patient use vials at a cost of $1,200 per pack or $300 per vial."Many people complain that a double chin makes them feel older and heavier than they actually are," said Frederick C. Beddingfield, III, M.D., Ph.D., Chief Medical Officer, KYTHERA. "With KYBELLA™, for the first time, people have access to a non-surgical solution to address this long-standing but common aesthetic complaint. KYBELLA™ causes the destruction of fat cells, so once the aesthetic response is achieved, retreatment is not expected." KYBELLA™ is administered by injections into the fat under the chin, tailored to the treatment goals of the patient and their physician. In clinical trials, many patients experienced visible results in two to four treatments,[i] though up to six treatments may be administered. The average dose was 2-3 vials per treatment session (which equates to 4-6 mL). KYBELLA™ treatment resulted in high patient satisfaction during clinical trials. In fact, 79 percent of KYBELLA™-treated patients reported satisfaction with their appearance in association with their face and chin. Patients also reported improvement in the visual and emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat. Health care practitioners and consumers can visit www.MyKYBELLA.com for further product and prescribing information, and to find physicians who have been trained on the use of KYBELLA™. KYBELLA™ is supported by a global clinical development program that includes over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA™.[ii] The most common adverse reactions were associated with the injection site and included swelling, bruising, pain, numbness, erythema and formation of areas of hardness in the treatment area. The percentage of adverse reactions reported as mild were 81 percent, moderate 17.4 percent, and severe 1.6 percent. In clinical trials, the incidence and severity of most side effects decreased with subsequent KYBELLA™ treatments. KYBELLA™ can cause serious side effects, including trouble swallowing (2% of clinical trial patients) and nerve injury in the jaw that can cause an uneven smile or facial muscle weakness (4% of clinical trial patients). Adverse reactions resulted in study discontinuation in 1.6 percent of subjects.
About Submental Fullness Submental fullness is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearance[iii] – leading to an older and heavier look.[iv] Submental fullness can affect adults – both women and men – of all ages, weight and gender. Influenced by multiple factors including aging and genetics, submental fullness is often resistant to diet and exercise. According to a survey by the American Society for Dermatologic Surgery (ASDS), nearly as many consumers are bothered by submental fullness (68%) as by lines and wrinkles around the eyes (71%).[v]
About KYBELLA™ KYBELLA™ is the first and only approved injectable drug for contouring moderate to severe submental fullness, a condition that is commonly referred to as a double chin. KYBELLA™ is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.[vi] When injected into subcutaneous fat, KYBELLA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.[vii] KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The safe and effective use of KYBELLA™ for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
Important Safety Information KYBELLA™ should only be administered by a trained healthcare professional. KYBELLA™ is contraindicated in the presence of infection at the injection sites. Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage. Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA™ should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days). Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA™ in these patients as current or prior history of dysphagia may exacerbate the condition. In clinical trials, 72% of subjects treated with KYBELLA™ experienced injection site hematoma/bruising. KYBELLA™ should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur. To avoid the potential of tissue damage, KYBELLA™ should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles. The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
About KYTHERA® KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. In addition to its lead product KYBELLA™, KYTHERA also licensed the worldwide rights to setipiprant (KYTH-105), an early-stage potential treatment for hair loss. KYTHERA's longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. KYTHERA has submitted regulatory filings for ATX-101 in Canada, Switzerland and Australia. Find more information at www.kythera.com.
No comments:
Post a Comment