Janssen Pharmaceutical wins FDA breakthrough therapy designation for investigational prophylactic vaccine for prevention of respiratory syncytial virus.
M2 PHARMA-September 4, 2019-Janssen Pharmaceutical wins FDA breakthrough therapy designation for investigational prophylactic vaccine for prevention of respiratory syncytial virus
(C)2019 M2 COMMUNICATIONS
Pharmaceutical company Janssen Pharmaceutical Companies reported on Tuesday the receipt of US Food and Drug Administration (FDA) Breakthrough Therapy Designation for its investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults.
The company added that the investigational prophylactic vaccine is currently in a Phase 2b proof of concept study to investigate the safety and efficacy of the vaccine against RSV in adults aged 65 years and older.
Older adults aged 60 years or older are among the populations at highest risk of developing RSV, a highly-contagious, potentially life-threatening respiratory infection. RSV is a leading cause of bronchitis and pneumonia, affecting more than 64m people each year worldwide.
This US FDA breakthrough therapy designation was based on clinical data from the company's prophylactic RSV senior vaccine that may demonstrate substantial improvement compared to available standard of care on a clinically significant endpoint(s).2
Following the US FDA Breakthrough Therapy Designation, the company's prophylactic RSV senior vaccine candidate is now eligible for all associated FDA features.
((Comments on this story may be sent to firstname.lastname@example.org))
|Printer friendly Cite/link Email Feedback|
|Date:||Sep 4, 2019|
|Previous Article:||APhA elects Ilisa Bernstein as VP of pharmacy practice and government affairs.|
|Next Article:||Zealand Pharma announces advancement by Boehringer Ingelheim of dual-acting GLP-1/glucagon agonist BI 456906 to phase 2 clinical testing in...|