FDA批准首个草花粉过敏治疗药物Oralair

美国食品药品管理局(FDA)4月1日已批准Oralair用于治疗过敏性鼻炎，这是美国批准的首个过敏原提取物舌下制剂。

Oralair的适应症是用于某些草花粉引起的伴有或不伴有眼部炎症的10~65岁过敏性鼻炎患者的治疗。生产商申请该药物用于年龄≥5岁的患者。

该药物含有5种草的冷冻干燥提取物：肯塔基蓝草、鸭茅、多年生黑麦草、甜春季草和梯牧草。

美国过敏、哮喘和免疫学会前任主席、佛罗里达州劳德代尔堡执业过敏症专科医生Linda Cox医生称，舌下片治疗将为美国每年约3,000万过敏性鼻炎受累患者提供治疗选择。Oralair每日一次，草花粉季节来临前4个月开始服用并持续整个季节。首次服药在医生诊室，后续可在家中自行服用。制造商格里尔实验室(Greer Laboratories)声称，Oralair可减少患者首个服药过敏季节草花粉导致的过敏症状。

她认为这是一个颠覆过敏性鼻炎治疗格局的产品。 “舌下免疫疗法提供了一种家庭治疗和更易获得的治疗手段，因为其安全性非常好。这可能使得该药物可用于大约90%的没有服用其他药物而仅仅是为治疗症状的患者。”

她还指出，Oralair对过敏性鼻炎标本兼治。“这将适用于正在遭受过敏季节痛苦以及使用各种产品没有达到最佳控制的人群，使他们有可能彻底摆脱疾病痛苦。”

Oralair批准令是基于在美国和欧洲纳入2,500多例成人和儿童患者的双盲安慰剂对照试验结果。为评估该药物的有效性，患者报告其症状和为控制过敏症状需要服用其他药物的情况。在一个草花粉季节治疗期间，与服用安慰剂患者相比， Oralair服用者症状和需要其他药物治疗减少16~30%。

试验表明，过敏季节前和过敏季节期间服用Oralair可减少患者过敏症状以及对症状缓解药物的需求。

据格里尔公司4月1日的声明，Oralair最常见不良事件为口腔瘙痒、咽喉刺激、耳部瘙痒、口部水肿、舌部瘙痒、咳嗽以及口咽部疼痛，发生率均小于5%。

Oralair于2008年首次在欧洲获批，目前已在31个国家获准上市。

By: REBECCA KERN, Internal Medicine News Digital Network

Oralair was approved April 1 by the Food and Drug Administration approved for the treatment of allergic rhinitis; it is the first sublingual allergen extract approved for use in the United States.

Oralair is indicated to treat allergic rhinitis with or without eye inflammation that is induced by certain grass pollens in people aged 10-65 years. The company had proposed that the treatment be approved for patients aged 5 years and older.

The treatment contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy.

Once-daily Oralair is started 4 months prior to the grass-pollen season and continued throughout the season. The first dose is delivered in the doctor’s office, and the remaining doses can be self-administered at home. Manufacturer Greer Laboratories claims that Oralair may reduce grass allergy symptoms for patients within the first allergy season it is taken.

Treatment with a sublingual tablet would open up the treatment options for the approximately 30 million Americans who suffer from allergic rhinitis every year, said Dr. Linda Cox, immediate past president of the American Academy of Allergy Asthma and Immunology and a practicing allergist in Ft. Lauderdale, Fla.

She said that she sees it as a game changer for the treatment of allergic rhinitis.

"What sublingual immunotherapy offers is home treatment and easier access to care because its safety profile is so good," Dr. Cox said in an interview. "That could potentially open up this treatment for the 90% or so of patients who are not receiving anything and are just treating the symptoms."

She added that Oralair treats the underlying causes of allergic rhinitis, not just the symptoms caused by the disease. "It will bring a group of people who are just suffering through their [allergy] seasons and are getting suboptimal control with various products and give them the potential to just knock out their disease," she added.

Approval of Oralair was based on double-blind, placebo-controlled trials in the United States and Europe that enrolled more than 2,500 adults and children. To assess the treatment’s effectiveness, patients reported their symptoms and additional medications needed to cope with their allergy symptoms. During treatment for one grass-pollen season, patients taking Oralair saw a 16%-30% reduction in symptoms and the need for medications, compared with those who received a placebo.

The trials demonstrated that treatment with Oralair before and during allergy season reduced patients’ allergy symptoms and their need for symptom-relieving medication.

The most common adverse events for Oralair, reported in less than 5% of patients, were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain, Greer Laboratories said in an April 1 statement.

Oralair was first approved in Europe in 2008, and is currently approved in 31 countries.