Celgene重磅免疫性疾病口服药物Otezla获欧盟批准

Celgene重磅免疫性疾病口服药物Otezla获欧盟批准

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发布日期：2015-01-20  来源：生物谷  

Otezla是全球首个口服选择性PDE4抑制剂，与市售药物相比（包括年销$106亿的Humira和年销$83亿的Enbrel），Otezla具有口服及无需监测的巨大优势，年销售峰值将突破20亿美元。

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  生物技术巨头新基（Celgene）重磅口服药物Otezla（apremilast）近日在欧盟监管方面收获大好消息，欧盟委员会（EC）已批准Otezla用于2种自身免疫性疾病的治疗：（1）用于对其他系统疗法（包括环孢素、甲氨蝶呤或补骨脂素紫外线疗法（PUVA））治疗无响应、有禁忌或不耐受的中度至重度慢性斑块型银屑病（plaque psoriasis）成人患者的治疗；（2）作为单药或联合其他疾病修饰抗风湿药物（DMARDs）用于对先前DMARD疗法响应不足或已经不能耐受的活动性银屑病关节炎（PsA）成人患者的治疗。在美国，FDA分别于2014年3月和9月批准Otezla用于活动性银屑病关节炎（PsA）及中度至重度斑块型银屑病（plaque psoriasis）适应症。

Otezla是一种首创的口服、选择性磷酸二酯酶4（PDE4）抑制剂，该药是过去20年中获批用于银屑病治疗的首个口服药物，也是过去15年中获批用于银屑病关节炎的首个口服药物。在相关临床试验中，Otezla已被证明能够使患者病情取得具有临床意义的显著持久改善，该药将为广泛的银屑病患者群体提供了一种有价值的治疗选择，包括以前使用过生物制剂或常规系统性药物治疗的患者群体。

业界认为，尽管面临着注射型药物肿瘤坏死因子（TNF）抑制剂的竞争，尤其是全球最畅销的药物Humira（修美乐，艾伯维公司产品，2013年销售额106亿美元）和Entrel（恩利，辉瑞/安进产品，2013年销售额83亿美元），但Otezla临床用药不需要常规的实验室监测，而且该药是一种口服药物，相比市售注射药物，Otezla具有巨大优势，该药将为患者和医生提供一种重要的治疗选择。业界预期，Otezla的销售峰值将突破20亿美元。

银屑病（psoriasis）是一种由不受控免疫反应导致的皮肤慢性炎症性疾病，欧洲患者总数约为1400万例，全球患者总数超过1.25亿例。斑块型银屑病（plaque psoriasis）是最常见的疾病形式，约占银屑病病例的80%。约30%的银屑病患者可能发展为银屑病关节炎（PsA）。

Otezla（apremilast）是一种口服小分子磷酸二酯酶(PDE4)抑制剂，在细胞内调控促炎症和抗炎介质的网络。PDE4是一种环磷酸腺苷(cAMP)特异性PDE，是炎性细胞中主要的PDE。PDE4抑制可提升细胞内cAMP水平，通过调控TNF-α、IL-23和其他炎性细胞因子的表达相应下调炎性反应。cAMP升高也会增加抗炎细胞因子，例如IL-10。

英文原文：Oral OTEZLA® (apremilast) Approved by the European Commission for the Treatment of both Patients with Psoriasis and Psoriatic Arthritis

OTEZLA®, a selecive PDE4 inhibitor, is the first oral treatment in 20 years to receive approval for patients with psoriasis and in the last 15 years to receive approval for psoriatic arthritis1,2,3

OTEZLA® has demonstrated proven and durable efficacy in psoriasis, including difficult to treat areas such as scalp and nail, and in psoriatic arthritis, with improvement in swollen and tender joints, as well as dactylitis and enthesitis1

OTEZLA® has shown a favourable safety profile, with no European labelling requirement for drug-specific pre-screening or ongoing laboratory monitoring

BOUDRY, Switzerland--(BUSINESS WIRE)--

Celgene International Sàrl (CELG), a wholly-owned subsidiary of Celgene Corporation, today announced that the European Commission (EC) has granted marketing authorisation for OTEZLA® (apremilast), the company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:1

For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
“The approval of OTEZLA® is an important new option for the treatment of patients who are not experiencing adequate relief for their conditions. OTEZLA® has shown significant and clinically meaningful improvements in psoriasis and psoriatic arthritis, including difficult to treat areas such as nail, scalp, and itch, which can all be the cause of great burden for patients,” said Dr. Diamant Thaci, Professor of Dermatology and the Head of the Comprehensive Center of Inflammation and Medicine at the University of Lübeck, in Germany. “OTEZLA® has also been generally well tolerated and does not require routine laboratory monitoring, which can be beneficial for both physicians and patients.”

OTEZLA® is the first in a new class of medicines for the treatment of both psoriasis and psoriatic arthritis, two diseases involving dysregulated immune system activity. Psoriasis is a systemic inflammatory condition characterised by raised scaly lesions on the skin. It affects approximately 14 million people across Europe4 and about 125 million people worldwide.5 Plaque psoriasis, also called psoriasis vulgaris, is the most common form of the disease, representing approximately 80 percent of cases.6 Additionally, up to 30 percent of people with psoriasis may develop psoriatic arthritis. Psoriatic arthritis, which is also an immune-mediated disease, is estimated to affect nearly 38 million people worldwide7. It is a chronic condition characterised by pain, stiffness, swelling and tenderness of the joints, and a decrease in physical functioning.8 Enthesitis (inflammation at sites wher tendons or ligaments insert into bone) and dactylitis (inflammation of fingers and toes, commonly known as “sausage fingers and toes”) are specific disease manifestations related to psoriatic arthritis, which can contribute to significant disability.8,9

“The approval of OTEZLA® in Europe marks an important juncture in Celgene’s mission to follow the path of science and innovation wher the greatest unmet need resides, and wher we can make a considerable difference in the lives of people living with debilitating, inflammatory diseases,” stated Tuomo Pätsi, President, Celgene Europe, the Middle East and Africa (EMEA). “Patients with psoriasis and psoriatic arthritis may require lifelong treatment due to the chronic nature of their conditions, and we believe it is our responsibility to offer them a new option which could significantly reduce their symptoms and allow them to live a better life.”

The marketing authorisation is based on efficacy and safety data from two Phase III programs, ESTEEM AND PALACE, which demonstrate a maintained clinical response among patients with psoriasis (ESTEEM) and psoriatic arthritis (PALACE) treated with OTEZLA® through 52 weeks, across multiple endpoints.1,10

In the ESTEEM studies, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 (a 75 percent improvement in the Psoriasis Area Severity Index) scores at week 16, the primary endpoint. Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch,1 known to have a marked impact on patients’ quality of life and perception of disease severity.11

In the PALACE program, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20 percent improvement in the American College of Rheumatology disease activity criteria) response at week 16, the primary endpoint. Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, dactylitis, enthesitis and overall physical function and quality of life.1,9

Consistently, across these Phase III clinical studies, the most commonly reported adverse reactions were diarrhoea, nausea, upper respiratory tract infection, tension headache and headache. Gastrointestinal (GI) adverse reactions were mostly mild to moderate in severity, with 0.3% of diarrhoea and 0.3% of nausea reported as being severe. These adverse reactions generally occurred within the first two weeks of treatment and usually resolved within four weeks. Overall, most adverse reactions were considered to be mild or moderate in severity.1

The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in November 2014.12 OTEZLA® will be launched in the European unio in the coming months in accordance with local requirements.

OTEZLA® was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis and on September 23, 2014 for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Marketing authorisation applications are ongoing in other countries, including Australia and Switzerland.

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