默沙东提摩西草过敏舌下免疫含片Grastek获FDA批准

默沙东提摩西草过敏舌下免疫含片Grastek获FDA批准
[size=1.1em]作者：[size=1.1em]tomato[size=1.1em]来源：[size=1.1em]生物谷2014-4-16 8:44:00

关键词： 默沙东 提摩西草过敏 舌下免疫含片 Grastek

                               
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2014年4月16日讯 /生物谷BIOON/ --默沙东（Merck & Co）4月14日宣布，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）获FDA批准，该药是一种花粉提取物，旨在作为一种免疫疗法，用于经皮肤测试阳性及提摩西草或具有交叉反应的草花粉体外测试花粉特异性IgE抗体阳性确证为由草花粉诱发的过敏性鼻炎（伴有或无结膜炎）的治疗。Grastek获批用于5岁-65岁人群，不适用于过敏症状的即刻缓解。Grastek是唯一获批用于5岁儿童的舌下免疫含片。

Grastek是一种每日一次的提摩西草（Timothy）过敏舌下免疫含片，旨在帮助产生一种免疫反应，来帮助保护患者对提摩西草花粉的过敏，从而帮助治疗过敏性鼻炎的根本原因。

此前，默沙东于2013年11月公布的一项III期研究数据表明，与安慰剂相比，Grastek显著改善了整个花粉季节平均总复合得分（TCS），达到了研究的主要终点。

Grastek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Grastek产品中任何非活性成分过敏的群体。

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。

关于提摩西草过敏：

在美国，提摩西草是最常见的草本植物之一，已被证明与其他草本植物具有交叉反应，包括田春芬（sweet vernal）、鸭茅（cocksfoot）、多年生黑麦、六月草、草甸羊茅和鼎红。在美国不同区域草花粉季节各不相同。

英文原文：FDA Approves Merck’s GRASTEK® (Timothy Grass Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Grass Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Children and Adults

GRASTEK is the Only FDA Approved Sublingual Allergy Immunotherapy Tablet Indicated for Children as Young as 5 Years of Age

Monday, April 14, 2014 5:59 pm EDT

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 GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. GRASTEK is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK is approved for use in persons 5 through 65 years of age. GRASTEK is not indicated for the immediate relief of allergic symptoms.

The prescribing information for GRASTEK includes a boxed warning regarding severe allergic reactions. GRASTEK 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.

“Every grass pollen season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication,” said Dr. David Bernstein, professor of medicine and environmental health, Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine. “These patients often have multiple sensitivities. Some of these patients may be candidates for immunotherapy, but decline allergy shots. With the FDA approval of GRASTEK, allergy specialists now have a new sublingual approach to offer these patients for their grass allergies.”

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

“The FDA approval of GRASTEK brings an important new sublingual tablet for allergy specialists treating adults and children with allergic rhinitis with or without conjunctivitis caused by Timothy or cross-reactive grass pollens,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “This important milestone marks another opportunity for Merck to build on our respiratory heritage with allergy specialists.”

About Timothy grass allergy

Timothy grass is one of the most common grasses in the United States and has been demonstrated to be cross-reactive with other grasses, including sweet vernal, orchard (also known as cocksfoot), perennial rye, Kentucky blue (also known as June grass), meadow fescue and redtop. Timing of the grass pollen season varies regionally across the United States.

Dosing and administration of GRASTEK (Timothy Grass Pollen Allergen Extract)

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

The first dose of GRASTEK 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 GRASTEK 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. Children must take GRASTEK under adult supervision.

Initiate GRASTEK at least 12 weeks before the expected onset of each grass pollen season and continue treatment throughout the season. The safety and efficacy of in-season initiation have not been established.

For sustained effectiveness for one grass pollen season after cessation of treatment, GRASTEK may be taken daily for three consecutive years (including the intervals between the grass pollen seasons). The safety and efficacy of in-season initiation have not been established.

GRASTEK will be available in U.S. pharmacies in late April.

About the clinical study program for GRASTEK (Timothy Grass Pollen Allergen Extract)

The efficacy of GRASTEK was supported by two studies of approximately 24 weeks treatment duration over one grass season each in patients 5 through 65 years of age, and one 5-year grass pollen season study in patients 18 through 65 years of age. In all three randomized, double-blind, parallel-group, multi-center studies:

Patients had a history of grass pollen-induced allergic rhinitis with or without conjunctivitis, and sensitivity to grass confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass;
Patients with non-grass sensitivities were included as long as the patients did not require treatment as a result of symptoms from those non-grass allergies during the grass season;
GRASTEK or placebo was administered as a sublingual tablet and initiated approximately 12 weeks before the start of the grass pollen season;
Patients in both arms of the study were allowed to take symptom-relieving medications (including systemic and topical antihistamines, and topical and oral corticosteroids) as needed;
Efficacy was established by self-reporting of rhinoconjunctivitis daily symptom scores (DSS) and daily medication scores (DMS), the sums of which were combined into the total combined scores (TCS);
Daily rhinoconjunctivitis symptoms included four nasal symptoms (runny nose, stuffy nose, sneezing and itchy nose), and two ocular symptoms (gritty/itchy eyes and watery eyes).
The FDA criteria for clinically relevant efficacy of allergen immunotherapy is based on the TCS, which must have an average difference relative to placebo of less than or equal to -15 percent, and the upper bound of the 95 percent confidence interval (CI) must be less than or equal to -10 percent.

First season efficacy in adults and children

One study compared GRASTEK to placebo in 1,501 patients 5 through 65 years of age, of whom approximately 25 percent had mild, intermittent asthma and 85 percent were sensitized to other allergens in addition to grass. Patients treated with GRASTEK had significant reduction of nasal and ocular symptoms, and reduction in use of symptom-relieving allergy medication, as measured by a decrease in the TCS for the entire grass pollen season, compared to placebo; difference for GRASTEK (Timothy Grass Pollen Allergen Extract) (n=629) relative to placebo (n=672) was -23 percent (95% CI: -36.0%; -13.0%).

A second study compared GRASTEK to placebo in 344 patients 5 through 17 years of age, of whom 26 percent had mild, intermittent asthma and 89 percent were sensitized to other allergens in addition to grass. Patients treated with GRASTEK had significant reduction of nasal and ocular symptoms, and reduction in use of symptom-relieving allergy medication, as measured by a decrease in the TCS for the entire grass pollen season, compared to placebo; difference for GRASTEK (n=149) relative to placebo (n=158) was -26 percent (95% CI: -38.2%; -10.1%).

Sustained effect

In one 5-year study, 634 patients 18 through 65 years of age received GRASTEK or placebo for three consecutive years and were then observed for two years during which they did not receive study drug. Patients treated with GRASTEK had a decrease in TCS throughout the grass pollen season during the three years of active treatment. This effect was sustained during the grass pollen season in the first year after discontinuation of GRASTEK, but not in the second year.

TCS difference (GRASTEK relative to placebo) per year:Year 1: -34% (95% CI: -42.0%;-26.3%); (n=568*)

Year 2: -41% (95% CI: -51.8%;-29.5%); (n=316*)
Year 3: -34%;(95% CI: -45.5%;-21.4%); (n=287*)
Post Treatment Year 1: -27% (95% CI: -39.9%;-12.4%); (n=257*)
*Number of patients in analysis in both treatment groups (GRASTEK and placebo).

About allergic rhinitis due to Timothy and cross-reactive grasses

It is estimated that approximately 7.5 million U.S. children and adults ages 5 to 64 have been diagnosed with moderate to severe allergic rhinitis and are sensitized to Timothy and cross-reactive grass pollens.

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