Noven Pharmaceuticals,Inc.プレスリリ－ス:ノーベン社はMinivelle®（エストラジオール経皮システム）の新用量において米国食品医薬品局から新たな効能効果の承認を取得
2014-09-26 · Hisamitsu Pharmaceutical Co., Inc. · original hisamitsu.co.jp ↗
Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle® (Estradiol Transdermal System) Minivelle now approved for prevention of postmenopausal osteoporosis at all doses New 0.025 mg/day Minivelle, for osteoporosis only, is the smallest estrogen patch ever Miami, FL and New York, NY, September 24, 2014 -- Noven Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes. With this new approval, women who are using Minivelle to treat their VMS symptoms have the benefit of also helping to prevent osteoporosis. The new 0.025 mg/day patch is 33% smaller than Minivelle 0.0375 mg/day that is already only about the size of a dime, the planet’s smallest estrogen therapy patch ever. Minivelle is now approved with five dosing options – 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day, with the newly approved, lower dose of 0.025 mg/day indicated for the prevention of postmenopausal osteoporosis only. If a patient uses Minivelle only to prevent osteoporosis from menopause, they should talk with their healthcare provider about whether a different treatment or medicine without estrogens might be better for them. “Noven is deeply committed to offering therapies that address women’s menopausal health,” said Joel Lippman, M.D., FACOG, Noven’s Executive Vice President – Product Development and Chief Medical Officer. “We’re pleased that we now have an additional indication and the new dosage strength available for Minivelle to allow women and their doctors to individualize their treatment to best fit their needs.” The new lower dose of 0.025 mg/day is expected to be available in pharmacies in January 2015. Noven offers a savings program to help reduce the Minivelle co-pay for eligible patients. Eligible patients pay no more than $15 each month for up to 12 uses on their Minivelle prescriptions. Restrictions may apply. For more information, including full terms and conditions, visit www.MINIVELLE.com. About Minivelle® Minivelle is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes, and the prevention of postmenopausal osteoporosis. If a patient uses Minivelle only to prevent osteoporosis from menopause, they should talk with their healthcare provider about whether a different treatment or medicine without estrogens might be better for them. Minivelle is bioequivalent to Vivelle® (estradiol transdermal system), which demonstrated safety and efficacy for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes. Efficacy and safety of Vivelle in the prevention of postmenopausal osteoporosis have been demonstrated in a 2-year double-blind, randomized, placebo-controlled, parallel group study. No clinical trials were conducted with Minivelle. The most commonly reported adverse events for Vivelle (≥5 percent) were headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses, and irregular vaginal bleeding or spotting. Minivelle contains bioidentical estradiol, a plant-based estrogen that is chemically identical to the estrogen produced naturally by a woman’s body. Minivelle is designed to release estradiol continuously upon application, increasing estradiol levels above baseline within four hours, and, with Noven’s transdermal drug delivery technology, allows for efficient delivery of estradiol through the skin, bypassing first pass metabolism. This does not mean that Minivelle is safer or more effective than other hormone therapies. Minivelle is round with smooth, curved edges that may help prevent lifting or snagging associated with everyday wear and stays in place during showering and exercising. It leaves almost no sticky residue and causes almost no skin irritation. During clinical pharmacology studies with Minivelle, 35 percent or less of subjects experienced barely perceptible erythema. At 1.65 cm2, the new 0.025 mg/day patch is 33% smaller than Minivelle 0.0375 mg/day that is already only about the size of a dime. Minivelle is now approved with five dosing options – 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day with the newly approved, lower dose of 0.025 mg/day indicated for the prevention of postmenopausal osteoporosis only. Please read the Important Safety Information below and for more information, including the full Prescribing Information, visit www.MINIVELLE.com. INDICATION MINIVELLE® (estradiol transdermal system) is a prescription medicine patch that contains estradiol (an estrogen hormone). MINIVELLE is used to treat moderate to severe hot flashes due to menopause and for the prevention of postmenopausal osteoporosis. If you use MINIVELLE only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. IMPORTANT SAFETY INFORMATION What is the most important information I should know about MINIVELLE (an estrogen hormone)? x Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using MINIVELLE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause x Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function) x Using estrogen-alone may increase your chances of getting strokes or blood clots x Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older x Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia x Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots x Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older x You and your healthcare provider should talk regularly about whether you still need treatment with MINIVELLE MINIVELLE should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its ingredients, or think you may be pregnant. The most common side effects that may occur with MINIVELLE are headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses and irregular vaginal bleeding or spotting. MINIVELLE should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. About Noven Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products, with a therapeutic focus in women’s health, and substantial expertise in transdermal drug delivery. Noven is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves as Hisamitsu’s U.S. growth platform in prescription pharmaceuticals. For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english. Vivelle is a registered trademark of Novartis AG. # # # Contacts Joseph C. Jones Vice President – Corporate Affairs Noven Pharmaceuticals, Inc. 305-253-1916 Ashley Buford Director Golin 212-373-6045 ʲྉʳ ͜ͷྉϊʔϕϯɾϑΝʔϚγϡʔςΟΧϧࣾʢҎԼɺϊʔϕϯࣾʣ͕ɺ2014 9݄24 ʢؒ࣌ʣʹൃදͨ͠ϓϨεϦϦʔεΛޠʹ༁ͨ͠ͷͰɺ༰͓Αͼղऍʹ͍ͭ ͯޠ͕༏ઌ͞Ε·͢ɻ ϊʔϕϯࣾ Minivelle®ʢΤετϥδΦʔϧൽγεςϜʣͷ৽༻ྔʹ͓͍ͯ ہ͔Β৽ͨͳೳՌͷঝೝΛऔಘ Minivelle ͯ͢ͷ༻ྔʹ͓͍ͯɺૈᱷͷ༧ༀͱͯ͠ঝೝ͞Ε·ͨ͠ɻ ৽ͨͳ 0.025mg/ͷૈᱷͷΈΛదԠͱͨ͠ Minivelle ɺ ͜Ε·ͰͰখαΠζͷΤετϩήϯࡎͰ͢ɻ 2014 9݄24 ࠃϑϩϦμभϚΠΞϛࢢ͓ΑͼχϡʔϤʔΫभχϡʔϤʔΫࢢʵϊʔϕ ϯࣾɺຊɺૈᱷͷ༧ༀ MinivelleʢΤετϥδΦʔϧൽγεςϜʣͷ৽༻ྔ ʹ͓͍ͯɺہʢFDAʣ͕৽ͨͳೳՌΛঝೝͨ͠ͱൃද͠·ͨ͠ɻFDA ɺ 2012 10݄ʹɺҰൠతʹͷ΅ͤͱͯ͠ΒΕ͍ͯΔܦʹҼ͢Δத͔Βͷӡ ಈঢ়ʢVMSʣΛྍ͢Δ Minivelle Λঝೝ͠·ͨ͠ɻճͷ৽ͨͳঝೝʹΑΓɺVMSྍͷͨ Ίʹ Minivelle Λ༻͢Δঁੑɺૈᱷͷ༧ͷखॿ͚ಘΒΕΔ͜ͱʹͳΓ·͢ɻ ৽ͨͳ 0.025 mg/ͷࡎɺ͢Ͱʹ 10 ηϯτ՟ͱಉఔͷେ͖͞Ͱ͋ͬͨ 0.0375 mg/ ͷ Minivelle ΑΓ͞Βʹ 33ˋখ͘͞ɺ࠷খͷΤετϩήϯࡎͰ͢ɻ Minivelle ࡏݱɺ0.025 mg/ɺ0.0375 mg/ɺ0.05 mg/ɺ0.075 mg/ɺ0.1 mg/ͷ 5 ͭͷ ༻ྔͰঝೝ͞Ε͍ͯ·͢ɻ৽ͨʹঝೝ͞Εͨ 0.025 mg/ͷ༻ྔࡎɺૈᱷͷ༧ ͷΈΛೳՌͱ͍ͯ͠·͢ɻऀ͕ Minivelle Λૈᱷͷ༧ͷͨΊ͚ͩʹ͏ ߹ɺऀऀͱɺҟͳΔྍΤετϩήϯΛؚ·ͳ͍ༀͷํ͕దͰͳ͍͔Λ૬ஊ ͢Δඞཁ͕͋Γ·͢ɻ ʮϊʔϕϯࣾɺঁੑͷظܦͷ߁݈ʹରԠ͢Δྍ๏Λڙ͢Δ͜ͱʹ৺ʹऔΓΜͰ͍· ͢ɻʯͱϊʔϕϯࣾͷ։ൃ෦ͷڃͰ͋ΓɺҩྍऀͰ͋Δ Joel S. Lippman ࢜ड़͍ͯ·͢ɻ͞Βʹɺʮࢲͨͪɺճ Minivelle ʹ͍ͭͯՃͷޮ Ռͱ৽ͨͳ༻ྔΛಘͨ͜ͱͰɺঁੑͱͦͷࢣ͕ͨͪχʔζʹ࠷க͢ΔผͷྍΛݱ࣮Ͱ ͖Δ͜ͱΛɺ͏Ε͘͠ࢥ͍ͬͯ·͢ɻʯͱଓ͚͍ͯ·͢ɻ ৽͍͠ 0.025 mg/ͷ༻ྔࡎɺ2015 1݄͔ΒؔػͰೖखՄೳʹͳΔ༧ఆͰ͢ɻϊ ʔϕϯࣾɺMinivelle ͷෛ୲ֹΛݮΒͨ͢Ίʹɺ݅Λຬͨ͢ऀ͞Μʹରͯ͠ॿ ੍Λڙ͍ͯ͠·͢ɻ݅Λຬͨ͢ऀ͞ΜɺMinivelle ͷॲํᝦʹ͖ͭ 12 ճ·Ͱͷར༻Ͱɺ ݄15 υϧΛݶͱ͍ͨ͠ͱͳΓ·͢ɻ੍ͷར༻ʹ͕݅͋Γ·͢ɻߋͳΔใ ʹ͍ͭͯɺ݅ͷશจΛؚΉ www.MINIVELLE.com Ͱೝ͍ͯͩ͘͠͞ɻ Minivelle®ʹ͍ͭͯ Minivelle Ұൠతʹͷ΅ͤͱͯ͠ΒΕ͍ͯΔܦʹҼ͢Δத͔Βͷӡಈঢ় ͷྍͱૈᱷͷ༧ʹదԠ͞Ε·͢ɻऀ͕ Minivelle Λૈᱷͷ༧ͷͨ Ί͚ͩʹ͏߹ɺऀऀͱɺҟͳΔྍΤετϩήϯΛؚ·ͳ͍ༀͷํ͕దͰ ͳ͍͔Λ૬ஊ͢Δඞཁ͕͋Γ·͢ɻ Minivelle Vivelle®ʢΤετϥδΦʔϧൽγεςϜʣͱతʹಉͰ͋ΓɺҰൠతʹͷ΅ ͤͱͯ͠ΒΕ͍ͯΔܦʹҼ͢Δத͔Βͷӡಈঢ়Λྍ͢ΔͨΊͷ҆શੑ ͱೳΛ༗͍ͯ͠·͢ɻVivelle ͷૈᱷͷ༧ʹ͓͚Δೳͱ҆શੑɺ2ؒʹΘͨ Δ๏ɺҙநग़๏ɺϓϥηϘֱɺֱͰࣔ͞Ε͍ͯ·͢ɻMinivelleࣗͷ ݧࢼߦΘΕ͍ͯ·ͤΜɻVivelle ͷݧࢼʹ͓͍ͯɺ࠷Α͘ݟΒΕͨ༻ʢ5%Ҏ্ʣ ɺ಄௧ɺೕͷѹ௧ɺഎ෦௧ɾ௧ɺɺফԽෆྑɺѱ৺ɺԌɺ݂Ͱ͢ɻ Minivelle ɺόΠΦΞΠσϯςΟΧϧɾΤετϥδΦʔϧɺ͢ͳΘͪঁੑͷମ͔Βવʹੜ ͞ΕΔΤετϩήϯͱతʹͷ২༝དྷͷΤετϩήϯΛؚΈ·͢ɻMinivelle ༻ʹࡍ͠ଓతʹΤετϥδΦʔϧΛ์ग़ͤ͞ΔΑ͏ܭ͞Ε͓ͯΓɺΤετϥδΦʔϧϨϕϧ Λ 4Ҏʹ४Ҏ্ʹҾ্͖͛·͢ɻϊʔϕϯࣾʹΑΔज़ʹΑΓɺॳճ ௨աՌΛճආͯ͠ΤετϥδΦʔϧΛൽෘ͔ΒՌతʹૹୡ͢Δ͜ͱ͕Մೳͱͳ͍ͬͯ·͢ɻ ͜ΕଞͷϗϧϞϯྍͱֱͯ͠ Minivelle ͕ΑΓ҆શͰՌతͰ͋Δͱ͍͏͜ͱΛҙຯ͠· ͤΜɻ Minivelle ɺͳΊΒ͔Ͱɺ֯ͷͳؙ͍͍ঢ়Λ͓ͯ͠ΓɺணҥʹΑ͕ͬͯΕͨΓ΄ͭΕͨΓ ͠ʹ͘͘ͳ͍ͬͯ·͢ɻͦͯ͠ɺೖཋதӡಈத͕ΕΔ͜ͱ͋Γ·ͤΜɻ͖͕ͨͭΔ ͜ͱ΄ͱΜͲͳ͘ɺൽෘͷ͔ͿΕΛҾ͖ى͜͢͜ͱ΄ͱΜͲ͋Γ·ͤΜɻMinivelle ͷྟচ ڀݚֶʹ͓͍ͯɺऀͷ 35ˋͦ͘͠ΕະຬͰɺΘ͔ͣʹࣝͰ͖Δൗ͕ೝ͞ Ε͍ͯ·͢ɻ ৽ͨͳ 0.025 mg/ͷࡎ 1.65 ὔͰɺ͢Ͱʹ 10 ηϯτ՟ͱಉఔͷେ͖͞Ͱ͋ͬͨ 0.0375 mg/ͷ Minivelle ΑΓ 33ˋখ͍͞αΠζͰ͢ɻMinivelleࡎࡏݱɺ0.025 mg/ɺ 0.0375 mg/ɺ0.05 mg/ɺ0.075 mg/ɺ0.1 mg/ͷ 5 ͭͷ༻ྔͰঝೝ͞Ε͍ͯ·͢ɻ৽ͨʹ ঝೝ͞Εͨ 0.025 mg/ͷࡎɺૈᱷͷ༧ͷΈΛೳͱ͍ͯ͠·͢ɻ هͷ ॏ ཁ ͳ ҆ શ ใ Λ ͓ ಡ Έ ͘ ͩ ͞ ͍ ɻ ຢ ɺ ॲ ํ ใ ΛؚΉࡉʹ ͭ ͍ ͯ ɺ www.MINIVELLE.com Ͱ͝ೝ͍ͩ͘͞ɻ దԠ MINIVELLEʢΤετϥδΦʔϧൽγεςϜʣɺΤετϥδΦʔϧʢΤετϩήϯϗϧϞϯʣ ΛؚΉҩྍ༻ҩༀͷࡎͰ͢ɻMINIVELLE ɺܦʹҼ͢Δத͔Βͷ΄ͯΓͷ ྍ͓Αͼૈᱷͷ༧ʹదԠ͞Ε·͢ɻ MINIVELLE ΛܦʹҼ͢Δૈᱷͷ༧ͷͨΊ͚ͩʹ͏߹ɺऀͱɺҟͳΔ࣏ ྍΤετϩήϯΛؚ·ͳ͍ༀͷํ͕దͰͳ͍͔Λ૬ஊ͍ͯͩ͘͠͞ɻ ॏཁͳ҆શใ MINIVELLEʢΤετϩήϯϗϧϞϯʣʹ͍ͭͯɺ͓͖ͬͯ͘࠷ॏཁͳใͳΜͰ͠ ΐ͏͔ʁ x Τετϩήϯ୯ಠͰͷ༻ɺٶࢠ͕ΜʹͳΔՄೳੑΛߴΊΔ͜ͱ͕͋Γ·͢ɻ MINIVELLE༻தɺ͍͔ͳΔ͔Βͷෆਖ਼݂ʹ͍ͭͯ࠲ʹࠂ͍ͯͩ͘͠͞ɻ ޙܦͷ͔Βͷ݂ɺࢠٶ͕Μͷঢ়Ͱ͋Δ߹͕͋Γ·͢ɻऀɺ ͍͔ͳΔ͔Βͷ݂ͦͷҼΛݟ͚ͭΔΑ͏νΣοΫ͢Δඞཁ͕͋Γ·͢ɻ x ױ࣬ɺ࡞ɺଔதɺೝʢೳͷԼʣͷ༧ʹΤετϩήϯΛ୯ಠͰ ༻͠ͳ͍Ͱ͍ͩ͘͞ɻ x Τετϩήϯ୯ಠͰͷ༻ɺଔதɺખʹͳΔՄೳੑΛߴΊΔ͜ͱ͕͋Γ·͢ɻ x 65Ҏ্ͷঁੑʹ͓͚Δݧ࣏ʹΑΕɺΤετϩήϯ୯ಠͰͷ༻ɺೝʹͳΔ ՄೳੑΛߴΊΔ͜ͱ͕͋Γ·͢ɻ x ͋ͳͨͱ͋ͳͨͷऀɺMINIVELLE ʹΑΔྍ͕Ҿ͖ଓ͖ඞཁͰ͋Δ͔Λఆ తʹ͠߹͏ඞཁ͕͋Γ·͢ɻ ͔Βͷෆਖ਼݂͕͋Δɺ؞͕͋Δຢ͋ͬͨɺଔத͋Δ͍࡞Λىͨ͜͜͠ͱ͕͋Δɺ ખ͕͋Δຢ͋ͬͨɺଁʹ͕͋Δຢ͋ͬͨɺױ࣬ͱஅ͞Ε͍ͯΔɺ MINIVELLE ຢͦͷʹΞϨϧΪʔ͕͋Δɺ৷ͷՄೳੑ͕͋Δ߹ʹ MINIVELLE Λ ͍͚ͬͯ·ͤΜɻ MINIVELLE ʹΑΓ࠷Α͘ى͜Γ͏Δ༻ɺ಄௧ɺೕͷѹ௧ɺഎ෦௧ɾ௧ɺɺ ফԽෆྑɺѱ৺ɺԌɺ݂Ͱ͢ɻ MINIVELLE ɺྍͷΰʔϧͱϦεΫΛகͨ͠༩ྔͱؒظͰɺ༻͢Δඞཁ ͕͋Γ·͢ɻ ϊʔϕϯࣾʹ͍ͭͯ ϊʔϕϯࣾɺҩྍ༻ҩༀͷڀݚɺ։ൃɺɺϚʔέςΟϯάɺൢചʹܞΘΔࣾͰ͋ Γɺঁੑͷ߁݈ͷͨΊͷྍʹಛԽ͠ɺༀૹୡγεςϜʹؔ͢Δ࣮ͨࣝ͠Λ༗͍ͯ͠ ·͢ɻϊʔϕϯࣾऀ٬ސɺۀࣄύʔτφʔʹͱͬͯॏཁͳརӹΛͨΒ͓͢Αͼज़ Λ։ൃɺڙ͢ΔͨΊਚྗ͍ͯ͠·͢ɻຢɺϊʔϕϯࣾຊͷༀͷࣾͰ͋ Γɺۀࣄʹ͓͍ͯༀάϧʔϓ͕ࠃͰ͢Δ൫ͱͯ͠ͷׂΛ୲͍ͬͯ ·͢ɻϊʔϕϯࣾʹ͍ͭͯͷใ www.noven.com Λ͝ཡ͍ͩ͘͞ɻༀʹ͍ͭͯ ͷใ www.hisamitsu.co.jp/english Λ͝ཡ͍ͩ͘͞ɻ Vivelle ɺϊόϧςΟε AG ͷొඪͰ͢ɻ ͓͍߹Θͤઌ Joseph C. Jones Vice President – Corporate Affairs ిɿ+1-305-253-1916 Ashley Buford Director Golin ిɿ+1-212-373-6045
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