注射用Qwo（溶组织性胶原酶梭菌）

公司名称：Endo International plc

批准日期：2020年7月6日

治疗：橘皮组织

Qwo（溶组织梭状芽胞杆菌酶）是细菌胶原酶的一种组合，可用于治疗成年女性臀部中度至重度的橘皮组织。

2020年7月6日Endo International plc今天宣布，它已获得美国食品药品监督管理局（FDA）批准的Qwo（胶原酶组织溶解梭状芽孢杆菌）用于治疗中度至重度橘皮组织在成年女性的臀部。 Qwo是首个获得FDA批准的脂肪疗法注射剂。

Endo总裁兼首席执行官Blaise Coleman说：“今天FDA对Qwo的批准，是继续执行Endo长期战略的一项关键成就，特别是与建立我们未来的业务组合和能力有关。” “随着Endo踏上令人振奋的医学美学新旅程，我们期待通过Endo Aesthetics组织将这种创新疗法推向市场。”

众所周知，橘皮组织是多因素病，但主要的促成因素是纤维结缔组织，称为“纤维隔膜”，其将皮肤垂直连接至下方的筋膜。2,3这些纤维隔膜将皮肤束缚在一起，向下拉4,5当被注入治疗区域时，Qwo被认为是通过特异性靶向1型和3型胶原蛋白以酶促方式释放纤维隔，这可能导致平滑化皮肤的外观和橘皮组织的改善外观。1

医学博士Matthew Davis表示：“ Endo认识到对脂肪团的有效，无创注射治疗的迫切需求，这使我们进行了美国脂肪团研究史上规模最大的临床试验。” ，Endo高级副总裁兼首席医学官。 “在严格的研究，测试和开发过程的支持下，我们很荣幸获得FDA批准的臀部脂肪注射剂的首个可注射治疗方法，我们期待将Qwo提供给美容界及其成年女性患者。”

Qwo的副作用包括注射部位瘀伤，疼痛，硬度区域和治疗区域的瘙痒。有关更多详细信息，请参见下面的重要安全信息。

“ Qwo可能会改变许多橘皮组织女性的游戏规则，”纽约联合广场激光皮肤科董事会认证的皮肤科医生安妮·查帕斯（Anne Chapas，M.D.）说。 “令我激动的是，现在将有一种经FDA批准的可注射疗法被证明可解决脂肪的根本原因。QWO令人兴奋的是，它是一种尖端的脂肪疗法，无需切割。”

预计Qwo将于2021年春季开始在美国各地的美容保健从业人员办公室发售。鼓励医师和消费者访问www.QWO.com并注册以获取有关产品可用性的最新信息。

什么是QWO？

Qwo是一种处方药，用于治疗成年女性臀部中度至重度的橘皮组织。

重要安全信息

如果您：对胶原酶或Qwo中的任何成分过敏，或在治疗区域感染，请勿接受Qwo。

Qwo可能会导致严重的副作用，包括：

•过敏（超敏）反应，包括过敏反应。如果您在服用Qwo后出现荨麻疹，呼吸困难，血压低，面部肿胀，胸痛，头晕或晕厥，请立即致电您的医疗保健提供者；

•注射部位瘀伤

在收到Qwo之前，请告诉您的医疗保健提供者您是否：

•有出血问题

•已怀孕或可能怀孕，正在哺乳或计划进行哺乳。您和您的医疗保健提供者应决定是否接受Qwo或母乳喂养。

告诉您的医疗保健提供者您服用的所有药物，包括处方药和非处方药，维生素和草药补品。尤其要告诉您的医疗保健提供者您是否服用了防止血液凝结的药物（抗血小板或抗凝剂）。

Qwo最常见的副作用包括：治疗部位的注射部位淤青，疼痛，硬度区域，瘙痒，发红，变色，肿胀和发热。

这些并非Qwo的所有可能副作用。致电您的医疗保健提供者以获取有关副作用的医疗建议。建议您通过www.fda.gov/medwatch或1-800-FDA-1088向FDA报告处方药的副作用。

关于橘皮组织

橘皮组织是皮肤轮廓的局部改变，据报道，在90％以上的青春期后女性中，橘皮组织影响着各个种族和族裔的女性。6,7橘皮组织的存在与皮肤厚度和皮肤厚度的变化有关。皮肤下面的脂肪细胞和结缔组织。8引起这种状况的主要因素是含有胶原的隔膜，该隔膜将皮肤附着在下面的筋膜层上。2,3隔膜将皮肤束缚在皮肤上，另外还有皮下突起脂肪会引起橘皮组织的表面凹陷。4,5雌性和雄性中这些纤维隔的取向不同，厚度不同，这有助于我们理解与性别相关的脂肪9。脂肪在临床上表现在臀部，大腿上。 ，小腹和手臂。6

众所周知，橘皮组织与全身性肥胖不同。10在全身性肥胖中，脂肪细胞会发生肥大和增生，而不仅限于骨盆，大腿和腹部。7在脂肪团区域，典型的代谢稳定的大型脂肪细胞具有生理和生化特性其特性不同于其他地方的脂肪组织.11 2019年的解剖研究发现，与男性相比，女性的脂肪小叶高度增加，这也可能是由于纤维隔膜的张力所致的床垫状外观.9 ，11体重增加可使脂肪团更引人注目，但脂肪团也可能存在于瘦弱的受试者中。

DUBLIN, July 6, 2020 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that it received U.S. Food and Drug Administration (FDA) approval of Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. Qwo is the first FDA-approved injectable treatment for cellulite.

"Today's FDA approval of Qwo is a key achievement in the continued execution of Endo's long-term strategy, especially as it relates to building our portfolio and capabilities for the future," said Blaise Coleman, President and Chief Executive Officer of Endo. "As Endo embarks on an exciting new journey into medical aesthetics, we look forward to bringing this innovative treatment to market through our Endo Aesthetics organization."

While cellulite is known to be a multifactorial condition, a primary contributing factor is the fibrous connective tissue, called the "fibrous septae," which connect the skin perpendicularly to the fascia below.2,3 These fibrous septae tether the skin, drawing it downward and leading to a mattress-like appearance, commonly referred to as "dimpling."4,5 When injected into the treatment area, Qwo is thought to release the fibrous septae enzymatically by specifically targeting Types 1 and 3 collagen, which may result in smoothing of the skin and an improved appearance of cellulite.1 

"Endo recognized a significant unmet need for an effective and non-invasive injectable treatment for cellulite, which led us to conduct the largest clinical trials in the history of cellulite investigation in the United States," said Matthew Davis, M.D., R.Ph., Senior Vice President and Chief Medical Officer of Endo. "Supported by rigorous research, testing and development processes, we are proud to have received FDA approval of the first injectable treatment for cellulite in the buttocks and we look forward to delivering Qwo to the aesthetics community and their adult female patients."

Side effects of Qwo included injection site bruising, pain, areas of hardness and itching in the treatment area.  Please see Important Safety Information below for more details.

"Qwo could be a game-changer for many women with cellulite," said Anne Chapas, M.D., a board-certified dermatologist at Union Square Laser Dermatology in New York City. "I am thrilled there will now be an FDA-approved injectable treatment option proven to address a root cause of cellulite. What is exciting about QWO is that it is a cutting-edge cellulite treatment, without the cutting."

Qwo is expected to be available throughout the United States at aesthetic healthcare practitioner's offices starting in Spring 2021. Physicians and consumers are encouraged to visit www.QWO.com and sign up for updates on product availability.

WHAT IS QWO?

Qwo is a prescription medicine used to treat moderate to severe cellulite in the buttocks of adult women.

IMPORTANT SAFETY INFORMATION

Do not receive Qwo if you: are allergic to collagenase or to any of the ingredients in Qwo, or have an active infection at the treatment area.

Qwo may cause serious side effects, including:

· Allergic (hypersensitivity) reactions, including anaphylaxis. Call your healthcare provider right away if you have hives, trouble breathing, low blood pressure, swollen face, chest pain, dizziness or fainting after receiving Qwo;

· Injection site bruising

Before receiving Qwo, tell your healthcare provider if you:

· have a bleeding problem

· are pregnant or may become pregnant, nursing or plan to nurse. You and your healthcare provider should decide if you will receive Qwo or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take a medicine that prevents the clotting of your blood (antiplatelet or anticoagulant). 

The most common side effects of Qwo include: injection site bruising, pain, areas of hardness, itching, redness, discoloration, swelling and warmth in the treatment area.

These are not all the possible side effects of Qwo. Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

About Cellulite

Cellulite is a localized alteration in the contour of the skin that has been reported in over 90 percent of post-pubertal females and affects women of all races and ethnicities.6,7 The presence of cellulite is associated with changes in dermal thickness and in the fat cells and connective tissue below the skin.8 A primary factor in the cause of the condition is the collagen containing septae which attach the skin to the underlying fascia layers.2,3 The septae tether the skin which, with additional contributing protrusions of subcutaneous fat, causes the surface dimpling characteristic of cellulite.4,5 These fibrous septae are oriented differently with varying thickness in females than in males, which informs our understanding of cellulite as a gender-related condition.9 Cellulite clinically presents on the buttocks, thighs, lower abdomen and arms.6 

It is known that cellulite is different from generalized obesity.10 In generalized obesity, adipocytes undergo hypertrophy and hyperplasia that is not limited to the pelvis, thighs, and abdomen.7 In areas of cellulite, characteristic large, metabolically stable adipocytes have physiologic and biochemical properties that differ from adipose tissue located elsewhere.11 An anatomical study in 2019 found that women have increased fat lobule height compared with men, which may also contribute to the mattress-like appearance seen as a result of the tension of the fibrous septae.9,11  Weight gain can make cellulite more noticeable, but cellulite may be present even in thin subjects.10

About Endo Aesthetics™ LLC

Endo Aesthetics is embarking on a mission devoted to pushing the boundaries of aesthetic artistry. Driven by world-class research and development, Endo Aesthetics is advancing solutions to address unmet needs beginning with the first FDA-approved injectable treatment for cellulite in the buttocks. Headquartered in Malvern, PA, Endo Aesthetics is an affiliate of Endo International plc (NASDAQ: ENDP). Learn more at www.endoaesthetics.com.

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly-focused specialty branded and generics pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

 Source: Endo International plc:

Posted: July 2020