Zogenix Receives Orphan Drug Designation for FINTEPLA® (Fenfluramine) in Japan
Retrieved on:
Thursday, August 26, 2021
Plasma protein binding, Lennox–Gastaut syndrome, Epilepsy, Private Securities Litigation Reform Act, Quality of life, CDD, U.S. Securities and Exchange Commission, SUDEP, MHLW, Orphan drug, Incidence, GLOBE, Labour, Ministry of Health, Labour and Welfare, Seizure, European Medicines Agency, Physician, Fenfluramine, Disease, Accreditation, Death, Ministry of Health (Saudi Arabia), Ministry, NASDAQ, Safety, Risk, Patient, Caregiver, Dravet syndrome, Mitochondrial disease, FDA, COVID-19, TK2, Pharmaceutical Affairs Law (Taiwan), Degenerative disease, Pharmaceutical industry, Residential care
The MHLW accreditation of Orphan Drug Designation follows the Japanese Pharmaceutical Affairs & Food Sanitation Councils (PAFSC) First Committee on Drugs agreement on July 28 to grant orphan drug designation for FINTEPLA for Dravet syndrome.
Key Points:
- The MHLW accreditation of Orphan Drug Designation follows the Japanese Pharmaceutical Affairs & Food Sanitation Councils (PAFSC) First Committee on Drugs agreement on July 28 to grant orphan drug designation for FINTEPLA for Dravet syndrome.
- The PAFSC is organized under the MHLW and consists of several expert committees from various fields, who serve as the decision-making body for drug approval (J-NDA, s-NDA) as well as Orphan Drug designation.
- In Japan, Orphan Drug Designation may be granted to drug candidates designed to treat diseases with fewer than 50,000 patients or diseases that are designated as intractable and the need for improved medical care is high.
- The orphan drug designation of FINTEPLA in Japan is an important milestone in our mission to meet the unmet needs of severe, rare epilepsy patients around the world, said Stephen J. Farr, Ph.D., President and Chief Executive Officer of Zogenix.