Navigation Links
Savara Pharmaceuticals Announces FDA Grant of Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Its Lead Product, AeroVanc
Date:12/10/2013

AUSTIN, Texas, Dec. 10, 2013 /PRNewswire/ -- Savara Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has designated the Company's lead antibiotic product, AeroVanc, as a Qualified Infectious Disease Product (QIDP) for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. The company also received Fast Track designation for AeroVanc pursuant to section 506(a)(1) of the Food and Drug Administration Safety and Innovation Act (FDASIA).

The QIDP and Fast Track designation provide AeroVanc access to certain incentives, including priority review associated with a New Drug Application (NDA) submission and an additional five years of exclusivity under the Hatch-Waxman Act upon FDA approval of AeroVanc. Last year AeroVanc received orphan designation, which provides the product seven years of market exclusivity, and various other incentives. 

"The recent QIDP status forms an important part of our market exclusivity strategy," says Rob Neville, CEO of Savara Pharmaceuticals. "This designation along with Orphan Drug status, our formulation patent protection and our inhalation device exclusivity creates a very robust protection from competition."

Savara Pharmaceuticals is currently conducting a nationwide Phase II clinical trial evaluating the safety and efficacy of AeroVanc in CF patients. For more information, please visit http://www.aerovanc.com.  

About AeroVanc
Vancomycin is an FDA-approved intravenously administered antibiotic with proven efficacy in the treatment of MRSA infections. AeroVanc is an investigational, proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. AeroVanc is currently being developed as a treatment for persistent MRSA lung infection in CF patients. By delivering vancomycin directly to the lungs, higher vancomycin concentrations are achieved at the site of infection, which is expected to lead to improved clinical efficacy. In addition, direct delivery of the drug into the lungs reduces exposure to the drug elsewhere in the body, and is thereby expected to reduce the risk of systemic drug-related side effects.

About Savara Pharmaceuticals
Savara Pharmaceuticals is a specialty pharmaceutical company developing AeroVanc (vancomycin hydrochloride inhalation powder), the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis. For more information, please see Savara's website at www.savarapharma.com, or www.aerovanc.com, or find us on Twitter, Facebook and LinkedIn.


'/>"/>
SOURCE Savara Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Savara Pharmaceuticals Appoints Two New Members to Its Board of Directors
2. Savara Pharmaceuticals Initiates Phase 2 Clinical Trial of AeroVanc for MRSA Lung Infection in Cystic Fibrosis Patients
3. Tech Coast Angels Contributes More Than $3 Million to $16 Million Savara Pharmaceuticals Series B
4. Savara Pharmaceuticals Announces Formation of Clinical Advisory Board
5. Savara Pharmaceuticals AeroVanc Granted U.S. Orphan Drug Designation for the Treatment of MRSA Lung Infection in Cystic Fibrosis Patients
6. Savara Pharmaceuticals Completes Phase I Clinical Study of AeroVanc in Cystic Fibrosis Patients
7. Actinium Pharmaceuticals to Present at the 24th Annual Oppenheimer Healthcare Conference
8. Neuraltus Pharmaceuticals NP001 Phase 2 Results Highlighted at the 24th International Symposium on ALS/MND
9. Imprimis Pharmaceuticals Announces Plans to Pursue Compounding Pharmacy Strategy in Accordance with the Recently Passed Drug Quality and Security Act
10. Actinium Pharmaceuticals Announces Clinical Advisory Board Meeting At The 2013 ASH Conference
11. Questcor Pharmaceuticals to Present at the Oppenheimer Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... June 26, 2016 One of Australia,s ... the formation of a new biotechnology company, Noxopharm Limited [ABN 50 ... an IPO and to list on the ASX. Noxopharm ... ready to enter a Phase 1 clinical study later this year. ... address one of the biggest problems facing cancer patients - the ...
(Date:6/26/2016)... DUBLIN , June 27, 2016 Jazz ... the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act ... proposed acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... 11:59 p.m. (Eastern Daylight Time). As previously ... entered into a definitive merger agreement under which Jazz ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ... , "Film editors can give their videos a whole new perspective by using the ... CEO of Pixel Film Studios. , ProSlice Levels contains over 30 Different presets ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the ... AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in ... topics including advance care planning, healthcare costs and patient and family engagement. , ...
(Date:6/25/2016)... FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial ... Plant City Observer , brings up a new, often overlooked aspect of head lice: the ... closing for fumigation is not a common occurrence, but a necessary one in the event ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
Breaking Medicine News(10 mins):