Acadia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Trofinetide for the Treatment of Rett Syndrome
Retrieved on:
Monday, July 18, 2022
Research, Neurology, FDA, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, People, Consensus, Schizophrenia, Disease, Risk, Communication, Psychosis, ACAD, Dementia, Hallucination, Neurological disorder, Nature, Delusion, Central nervous system, ASX, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nasdaq, U.S. Securities and Exchange Commission, Annual report, Private Securities Litigation Reform Act, Food, RPD, NINDS, Brain, Pain management, Physician, X chromosome, MECP2, Tarquinio Merula, Gait abnormality, Rett syndrome, Woman, Patient, Security (finance), LinkedIn, Priority review, Form 10-K, Safety, Twitter, CNS, Pediatric Neurology, NDA, Ageing, Lavandula, Sex swing, Neurology, Cognition, Female, Drug development, Clinical Global Impression, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., FDA, Neuron, Pharmaceutical industry, Birth control, Rett, Diagnosis
The RSBQ is a caregiver assessment of the core symptoms of Rett syndrome and the CGI-I is a global physician assessment of worsening or improving of Rett syndrome.
Key Points:
- The RSBQ is a caregiver assessment of the core symptoms of Rett syndrome and the CGI-I is a global physician assessment of worsening or improving of Rett syndrome.
- In 2018, Acadia entered into an exclusive license agreement with Neuren Pharmaceuticals Limited (ASX: NEU) for the development and commercialization of trofinetide for the treatment of Rett syndrome and other indications in North America.
- Trofinetide has been granted Fast Track Status and Orphan Drug Designation for the treatment of Rett syndrome in the United States.
- Trofinetide has been granted Fast Track Status and Orphan Drug Designation for Rett syndrome and has also been granted Rare Pediatric Disease (RPD) designation by the FDA.