Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Reviva Pharmaceuticals Receives FDA Orphan Designation

By Reviva Pharmaceuticals, Inc. | April 11, 2018

Reviva Pharmaceuticals, Inc. (Reviva), a privately held, clinical stage pharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its clinical stage drug candidate, RP5063, for the treatment of idiopathic pulmonary fibrosis (IPF).

“Obtaining the Orphan Drug Designation is a significant regulatory milestone as well as a notable achievement for Reviva, since it validates the significant therapeutic potential of RP5063 for the treatment of IPF,” said Laxminarayan Bhat, Ph.D., founder, president and CEO of Reviva. “IPF is a devastating disease with limited treatment options and no cure. RP5063, however, provides a novel mechanism of action that has the potential to impact multiple aspects of this disease and, combined with convenient delivery options, RP5063 affords hope to many patients suffering from this debilitating disease.”

RP5063 has shown robust efficacy in highly recognized translational animal models proven to emulate pulmonary fibrosis in humans. RP5063 significantly improved survival rate, reduced inflammatory cytokines and tissue scarring (fibrosis) in the lungs of bleomycin-induced pulmonary fibrosis animal model, indicating the potential for clinically meaningful improvement and stabilization of lung function. IPF and pulmonary arterial hypertension (PAH) are fatal lung diseases that share some common pathophysiology.

Recently, the FDA has also granted Orphan Drug Designation to RP5063 for the treatment of PAH. Thus, Reviva is planning to initiate phase 2 clinical trials for IPF and PAH in the very near future.

The FDA’s Orphan Drug Designation is granted for investigational drugs that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. With the orphan designation, Reviva qualifies for various incentives including FDA assistance in clinical trial design, tax credits for clinical trial costs, an exemption from the FDA user fee and seven years of market exclusivity in the United States from when market approval is granted.

(Source: Reviva Pharmaceuticals, Inc.)


Filed Under: Drug Discovery

 

Related Articles Read More >

FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
Lokavant’s Spectrum v15 uses AI to cut trial-feasibility modeling from weeks to minutes
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE