FDA Grants Breakthrough Therapy Designation to Tezepelumab for Severe Asthma

Officials with the FDA recently granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype, Amgen and AstraZeneca announced in a press release.
 
Tezepelumab is a potential first-in-class drug that blocks thymic stromal lymphopoietin (TSLP), an upstream modulator of multiple inflammatory pathways, according to Amgen. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control, according to the press release.
 
The designation is based on data from the phase 2b PATHWAY trial, which showed a significant reduction in the annual asthma exacerbation rate compared with a placebo over a 52-week treatment period.  
 
The trial evaluated the efficacy and safety of 3-dose regimens of tezepelumab as an add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting beta-agonist with or without oral corticosteroids and additional asthma controllers compared with a placebo. Participants included patients with severe asthma independent of baseline blood eosinophil count or other type 2 inflammatory biomarkers.
 
Overall, the data showed that annual asthma exacerbation rates were reduced by 62%, 71%, and 66% in the tezepelumab arms administered either 70 mg or 210 mg every 4 weeks or 280 mg every 2 weeks compared with a placebo, respectively.
 
“The Phase 2b PATHWAY trial data demonstrated tezepelumab’s promise as a novel therapeutic option for a broad population of patients with severe asthma, including those ineligible for currently approved biologic therapies,” David M Reese, MD, executive vice president of Research and Development at Amgen, said in a statement. “The Breakthrough Designation will give the opportunity to work closely with the FDA to bring tezepelumab to patients as quickly as possible.”
 
The most common adverse effects reported in the trial were asthma-related, nasopharyngitis, headaches, and bronchitis.
 
Tezepelumab is currently in development in the phase 3 PATHFINDER clinical trial program, which includes the 2 pivotal trials NAVIGATOR and SOURCE.   
 
Reference
Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype [news release]. Amgen’s website. https://www.amgen.com/media/news-releases/2018/09/tezepelumab-granted-breakthrough-therapy-designation-by-us-fda-for-the-treatment-of-patients-with-severe-asthma-without-an-eosinophilic-phenotype/. Accessed September 10, 2018.
 


Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 


Most Popular

Related Articles

Clinical trial demonstrates adoptive T-cell therapy may be successful in treating progressive multifocal leukoencephalopathy.
Olaparib (Lynparza, AstraZeneca and Merck), which is being investigated for the treatment of prostate cancer, receives its fourth orphan drug designation from the FDA.
Cheryl Allen, BSPharm, MBA, Vice President of Industry Relations at Diplomat Pharmacy, discusses the emergence of CAR T-cell therapy as a groundbreaking oncology treatment.
Company Profile >
Contributors >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Advertise
Careers
Contact Us
Terms & Conditions
Privacy
MJH Associates >
Pharmacy Times
OTCGuide
American Journal of Managed Care
Cure
MD Magazine
ONCLive
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2018
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.
 

$vacMongoViewPlus$