打开APP

默沙东第2款免疫含片获FDA批准

  1. Ragwitek
  2. 免疫疗法
  3. 短豚草过敏
  4. 舌下免疫含片
  5. 默沙东

来源:生物谷 2014-04-18 10:35

默沙东短豚草花粉过敏舌下免疫含片Ragwitek获FDA批准,这是本周默沙东获批的第二个舌下免疫含片。

2014年4月18日讯 /生物谷BIOON/ --默沙东(Merck & Co)4月17日宣布,FDA已批准Ragwitek(短豚草花粉过敏原提取物)舌下含片(12Amb a 1-U),该药首个也是唯一一个获FDA批准用于治疗短豚草花粉过敏症的舌下免疫含片。本月14号,默沙东提摩西草(Timothy)过敏舌下免疫含片Grastek(提摩西草花粉过敏原提取物)也获得了FDA的批准。此次Ragwitek获批,也意味着默沙东呼吸道产品组合中增添了第2个舌下免疫含片。默沙东计划于本月底即向美国市场推出该药。

Ragwitek是一种过敏原提取物,旨在作为一种免疫疗法,用于经皮肤测试阳性或体外测试花粉特异性IgE抗体阳性确证为由短豚草花粉诱发的过敏性鼻炎(伴有或无结膜炎)的治疗。Ragwitek获批用于18岁-65岁人群,不适用于过敏症状的即刻缓解。

Ragwitek的处方信息具有一个黑框警告,严禁用于伴有病情严重不稳定或不受控的哮喘群体、严禁用于有任何严重全身性过敏反应史的群体、严禁用于服用任何设下过敏免疫疗法后出现任何局部反应史的群体、严禁用于嗜酸性粒细胞性食管炎病史的群体、严禁用于对Ragwitek产品中任何非活性成分过敏的群体。

短豚草花粉引发的过敏性鼻炎(伴有或无结膜炎)包括打喷嚏、流鼻涕或鼻痒、鼻塞或发痒、眼睛流泪,通常会在花粉季节加剧。(生物谷Bioon.com)

英文原文:FDA Approves Merck’s RAGWITEK™ (Short Ragweed Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Short Ragweed Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Adults

RAGWITEK is the First and Only FDA Approved Sublingual Allergen Immunotherapy Tablet Indicated for the Treatment of Short Ragweed Pollen Allergies

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved RAGWITEK™ (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use (12 Amb a 1-U). RAGWITEK is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved for use in adults 18 through 65 years of age. RAGWITEK is not indicated for the immediate relief of allergic symptoms.

The prescribing information for RAGWITEK includes a boxed warning regarding severe allergic reactions. RAGWITEK is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.

"RAGWITEK provides a new sublingual approach to allergen immunotherapy for adult patients suffering from moderate to severe ragweed pollen allergies who have declined allergy shots," said Dr. David Skoner, director, Division of Allergy and Immunology, Allegheny Health Network, and a clinical investigator in Merck's sublingual allergen immunotherapy tablet program. "While there are regional variations, ragweed season typically starts in mid-August across the United States. During the season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication. These patients often have multiple sensitivities. To help prepare for the upcoming ragweed season, I would encourage patients diagnosed with ragweed pollen allergies to make an appointment now with an allergy specialist to discuss options."

Symptoms of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing, a runny or itchy nose, stuffy or congested nose, or itchy and watery eyes, and typically intensify during the ragweed pollen season.

“The FDA approval of RAGWITEK brings an important new option for allergy specialists treating adults with allergic rhinitis with or without conjunctivitis caused by short ragweed pollen,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “Merck is proud to add this second sublingual allergen immunotherapy tablet to our respiratory portfolio.”

About short ragweed pollen allergy

While regional variation exists, in many areas of the United States ragweed pollen season occurs from August to November. Ragweed pollen levels usually peak in mid-September in many parts of the country.

Dosing and administration of RAGWITEK (Short Ragweed Pollen Allergen Extract)

The recommended dose of RAGWITEK is one tablet daily to be placed under the tongue, where it will dissolve.

The first dose of RAGWITEK should be administered in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. The physician should observe the patient for at least 30 minutes after receiving the first dose of RAGWITEK to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home. The physician should prescribe auto-injectable epinephrine, and instruct and train the patient on its appropriate use.

Initiate RAGWITEK at least 12 weeks before the expected onset of ragweed pollen season and continue throughout the season. The safety and efficacy of initiating treatment in season have not been established.

RAGWITEK will be available in U.S. pharmacies by the end of April.

版权声明 本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。

87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->