Tags: Allergies | oralair | pollen | grass | allergy | drug

New Allergy Drug Gets Preliminary FDA Approval

Monday, 09 Dec 2013 04:10 PM

 

An oral immunotherapy aimed at grass and pollen allergies has a benefit and safety profile that supports its approval, according to briefing documents posted on Monday by the U.S. Food and Drug Administration ahead of a meeting by outside experts to discuss the drug.

Oralair, made by France's Stallergenes SA, would be the first such licensed therapy in the United States. It has been in use in Europe for several years.

The documents were posted prior to a meeting on Wednesday of an FDA advisory committee meeting that will provide a recommendation on whether the drug merits U.S. approval. The FDA considers advisory panel views when it decides whether to approve a drug, but is not obligated to follow its recommendation.

The FDA committee documents said that several large studies in Europe and the United States showed that the drug's efficacy was "robust" and "consistent." The documents said the treatment was "generally well-tolerated."

On Thursday, the committee will meet to discuss Grastek, an oral treatment for grass allergies that would be sold by Merck & Co. In Europe, Merck's partner, Danish company ALK Abello, sells the product as Grazax.

© 2015 Thomson/Reuters. All rights reserved.

Around the Web
Join the Newsmax Community
Please review Community Guidelines before posting a comment.
>> Register to share your comments with the community.
>> Login if you are already a member.
blog comments powered by Disqus
 
Email:
Country
Zip Code:
Privacy: We never share your email.
 
Hot Topics
Follow Newsmax
Like us
on Facebook
Follow us
on Twitter
Add us
on Google Plus
Around the Web
Top Stories
You May Also Like

At-Home Sleep Apnea Test Lets You Avoid Night in Clinic

Thursday, 29 Jan 2015 09:38 AM

Until recently, the only way to get tested for sleep apnea was to report for an overnight study at a sleep lab and let a . . .

Curcumin Supplements Reduce Disease-Causing Inflammation: Study

Thursday, 29 Jan 2015 08:30 AM

Adding spice - in the form of curcumin supplements - to the daily diets of people with risk factors for heart disease ma . . .

Ebola Vaccine Appears to Work in Preliminary Trial

Thursday, 29 Jan 2015 08:19 AM

Early results suggest an experimental Ebola vaccine triggers an immune response and is safe to use.
However, larger . . .

Most Commented

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

 
NEWSMAX.COM
America's News Page
©  Newsmax Media, Inc.
All Rights Reserved