ReAlta Life Sciences Announces EMA Orphan Drug Designation for RLS-0071 for the Treatment of Neonatal Encephalopathy

▴ ReAlta Life Sciences Announces EMA Orphan Drug Designation for RLS-0071 for the Treatment of Neonatal Encephalopathy
The EMA grants orphan status to medicinal products intended to treat rare disorders that affect fewer than 5 people per 10,000 in the European Union

ReAlta Life Sciences, Inc.,announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to RLS-0071 (also known as PIC1-dPEG24) for the treatment of neonatal encephalopathy. This designation builds on the Orphan Drug Designation that ReAlta received from the U.S. Food and Drug Administration (FDA) Office of Orphan Drug Products earlier this year.

“There is an urgent need for new therapeutic options to treat hypoxic-ischemic encephalopathy, a devastating condition that has a profound impact on newborns and their families,” said Ulrich Thienel, M.D., Ph.D., ReAlta’s Chief Executive Officer. “ReAlta is committed to supporting this vulnerable population and bringing forward the first pharmacological therapy for the treatment of HIE. The Orphan Drug Designation is recognition that RLS-0071 may be an important therapeutic option for this rare but serious condition.”

The EMA grants orphan status to medicinal products intended to treat rare disorders that affect fewer than 5 people per 10,000 in the European Union (EU). The designation provides certain benefits to the drug developer, including ten years of market exclusivity upon marketing authorization, fee reductions, and scientific advice during clinical development.

ReAlta intends to submit an Investigational New Drug (IND) application to the FDA for HIE in 2021 and begin HIE Phase 2 studies in neonates in the U.S., followed by a clinical trial application (CTA) to the EMA in support of phase 2 studies in Europe.

Neonatal encephalopathy is also known as hypoxic ischemic encephalopathy (HIE) or neonatal brain asphyxia. In this disease, otherwise normal healthy infants suffer from oxygen starvation to the brain. This can be caused by several processes, including placental tear or tight cord around the neck. These infants are typically otherwise healthy, and the event is abrupt and unanticipated. Many of these infants will die after birth or suffer permanent, life-long brain damage, such as severe mental retardation, or cerebral palsy, or both. HIE is frequently emotionally and financially devastating for the families of HIE babies. Worldwide, HIE is among the top three causes of infant death. The current state-of-the-art treatment for HIE is therapeutic hypothermia; there are currently no pharmacological therapies approved for HIE.

Tags : #ReAltaLifeSciences #LatestNewsonReAltaLifeSciences4thDec #LatestPharmaNews4thDec #EuropeanMedicinesAgency #OxyzenStarvation

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

American Institute of Pathology & Laboratory Sciences (Ampath) in Collaboration Expands its Diagnostic Services in PunjabMarch 26, 2025
AI Prodigy at 14: The Boy Who Might Save Millions from Heart DiseaseMarch 26, 2025
Delhi Finally Joins Ayushman Bharat But Is It Too Late to Fix Its Healthcare Crisis?March 26, 2025
Why Epilepsy Awareness Day Should Matter to EveryoneMarch 26, 2025
Why Epilepsy Awareness Day Should Matter to EveryoneMarch 26, 2025
A $10 Million Bet on Life: How Everhope Oncology Plans to Fix India’s Cancer CareMarch 26, 2025
Honoring Changemakers: Lighthouse Canton Supports Rotary Club of Bombay’s Shakti Awards 2025 as Platinum SponsorMarch 26, 2025
Death in the Shadows: What’s Behind the Rising Child Fatalities in Jharkhand?March 26, 2025
The Future of Autism Therapy? Why Roper is Betting Big on CentralReachMarch 25, 2025
Scientists unveil world-leading technology to speed up drug discoveryMarch 25, 2025
Moscow Scientists Develop Questionnaire to Evaluate Doctors' Trust in AI Services: A Tool for International StudiesMarch 25, 2025
Indian MedTech Leader Remidio invests in UK’s Occuity to Enhance Non-Invasive Global Disease ScreeningMarch 25, 2025
HRV Global Life Sciences Strengthens Global Presence at DCAT Week 2025 in New YorkMarch 25, 2025
Ola Electric-Ola Electric Settles Rosmerta Dues, Insolvency Petitions WithdrawnMarch 25, 2025
6 Symptoms of Kidney Disease You Shouldn’t IgnoreMarch 25, 2025
Mutations You Never Knew You Had: Is Your Stomach Secretly Turning Against You?March 24, 2025
World Tuberculosis Day: The Truth About Tuberculosis in IndiaMarch 24, 2025
Why Women Face a Greater Risk of Heart Disease Than MenMarch 24, 2025
Scientists to explore why Everest glacier is so warmMarch 24, 2025
Lupin Digital Health Introduces Comprehensive Post-Procedure Home-Based Care Guide in Collaboration with the American College of CardiologyMarch 24, 2025