英文药名: Raptiva(Efalizumab)

中文药名: 依法珠单抗注射剂

生产厂家: Serono Inc.

药品介绍

美国食品及药物管理局FDA最近批准了Raptiva （属名为efalizumab）可以用于治疗中度和严重慢性牛皮癣患者。这也是第二种获准用于治疗这类自身免疫性疾病的生物类制剂，类似的药物还包括Amevive、Enbrel和Remicade等。

Raptiva是一种定制抗体，这次获准的是每周一次的注射剂型（患者可以自己注射），其作用机制是攻击免疫系统中的特殊细胞以阻断牛皮癣的发病进程。FDA是根据近期完成的几项临床治疗研究结果作出上述批准的，这些研究中总共涉及到2，700多例中度和严重牛皮癣患者。一般性副作用包括头痛、寒战、恶心或肌肉酸痛等，通常发生在头两次注射期间，此后则不大出现。但有关专家依然提醒说，由于Raptiva是通过抑制免疫系统功能而作用的，因此有可能会相应增加感染的危险，尽管目前还不能确定是否会诱发癌症。

规格：150mg *4 支(盒)注射用粉剂

Raptiva(efalizumab)

FDA approves Raptiva™ (efalizumab) for chronic moderate-to-severe plaque psoriasis
First biologic therapy for psoriasis that can be self-administered once weekly, at home
RAPTIVA™ (efalizumab) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates for systemic therapy or phototherapy. RAPTIVA is the first biologic therapy that is designed to provide continuous control of chronic moderate-to-severe plaque psoriasis and can be self-administered by patients as a single, once-weekly, subcutaneous injection.

"Today's FDA approval of RAPTIVA underscores our commitment to delivering innovative therapies to patients with unmet medical needs," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "Through our collaboration with XOMA, the clinical trial investigators and most importantly, the over 2,700 patients who participated in our clinical trials, we are proud to offer a new therapeutic option to help patients manage this chronic disease."

"RAPTIVA represents XOMA's first product approval and is the culmination of a highly successful collaboration with Genentech," said John L. Castello, XOMA's chairman, president and chief executive officer. "The companies have worked together on a robust clinical program that has demonstrated the safety and efficacy of RAPTIVA. We view RAPTIVA now being available to
patients as a worthy testament to the confidence of our shareholders and the hard work and support of both companies'
employees."

"I've been treating psoriasis for over 15 years and have always been frustrated by the limited options available to treat patients with this chronic disease. Safety limitations of traditional therapies have made it difficult to offer patients continuous relief," said Craig Leonardi, M.D., clinical associate professor of dermatology of Saint Louis University, St. Louis, Mo. and a RAPTIVA clinical investigator. "RAPTIVA has the potential to break the cycle of intermittent therapy by offering patients and their doctors a convenient treatment regimen that can be used continuously."

RAPTIVA™ is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis symptoms. In clinical studies, RAPTIVA demonstrated a rapid onset of action in the reduction of symptoms associated with psoriasis, in some patients within four weeks of initiating treatment. RAPTIVA is administered once weekly via subcutaneous injection and can be self-administered by patients at home.

"Since there is no cure for psoriasis, people have to manage their disease over their lifetime. It is a major challenge to find a treatment that works, has a favorable track record for safety and can be easily integrated into a patient's life," said Gail M. Zimmerman, president and chief executive officer of the National Psoriasis Foundation. "RAPTIVA offers a new treatment option for psoriasis that because of its convenience and ease of administration may provide patients with a sense of control over their disease."

Genentech and XOMA are collaborating on the development of RAPTIVA in the United States. Serono S.A., Genentech's marketing partner outside the United States and Japan, announced earlier in the year that it had submitted a Marketing Authorization Application (MAA) to the European Agency for the Evaluation of Medicinal Products (EMEA) for European Union Approval of RAPTIVA in psoriasis. Serono has also submitted RAPTIVA data for marketing approval in Canada, Switzerland, Australia and New Zealand and is filing in additional countries.

Clinical Trial Results

The Biologics License Application (BLA) submission included data on more than 2,700 patients treated with RAPTIVA, representing the largest existing database of patients treated with a biologic therapy for psoriasis.

The FDA's approval decision was based on data from four randomized, placebo-controlled Phase III studies. The Phase III trials were designed to evaluate the safety and efficacy of RAPTIVA in treating chronic moderate-to-severe plaque psoriasis. The studies had a primary efficacy endpoint of 75 percent improvement in the Psoriasis Area and Severity Index (PASI). The PASI is a composite score that takes into consideration both the fraction of body surface area affected and the nature and severity of the psoriatic changes within the affected regions (erythema, infiltration/plaque thickness and desquamation). Secondary endpoints for the Phase III studies included physician assessment and patient-reported outcomes.

RAPTIVA demonstrated efficacy and maintained response in most patients after 12 weeks of treatment. Sustained responses to RAPTIVA have also been observed in uncontrolled open-label extension treatment trials when patients received RAPTIVA without interruption for 24 weeks.

Common adverse events that occurred at least two percent more frequently in RAPTIVA™ patients than in placebo included headache, infection (mostly upper respiratory infections), chills, nausea, pain, myalgia (muscle pain), flu syndrome, fever, back pain, and acne. Five of these events (headache, chills, fever, nausea and myalgia) were predominantly acute adverse events and were principally seen following the first two injections of RAPTIVA. For the third and subsequent doses, the incidence of acute adverse events was similar between the RAPTIVA and placebo groups. Less than one percent of patients were discontinued from treatment due to acute adverse events.

RAPTIVA is an immunosuppressive agent and has the potential to increase the risk of infection and reactivate latent, chronic infections. Many immunosuppressive agents have the potential to increase the risk of malignancy. The role of RAPTIVA in the development of malignancies is not known. Serious adverse events occurring in clinical studies with RAPTIVA were serious infections (0.4 percent in RAPTIVA vs. 0.1 percent in placebo), malignancy (the overall incidence of malignancies of any kind was 1.8 per 100 patient-years for RAPTIVA-treated patients compared with 1.6 per 100 patient-years for placebo-treated patients), thrombocytopenia (0.3 percent RAPTIVA vs. 0.0 percent placebo), and worsening of psoriasis, typically upon discontinuation (0.7 percent in RAPTIVA vs. 0.0 percent in placebo).