RHB-204 is eligible for FDA Rapid Review

The FDA's fast-track approval is designed to advance the development process and expedite review of new therapeutic drugs for serious illnesses that are not met with medical needs, with the aim of delivering important new drugs to patients more quickly.
with fast-track approval, RedHill will be able to communicate regularly with the FDA early to accelerate the RHB-204 development and receive a rolling review of the New Drug Application (NDA).
RHB-204 has been recognized as a Qualified Infectious Disease Product (QIDP) and has been eligible for NDA priority review and accelerated approval.
RHB-204 was also recently granted orphan drug eligibility, extending its FDA-approved market exclusive period to 12 years.
Red Hill recently launched a Phase 3 study to assess the safety and effectiveness of RHB-204 as a first-line treatment for lung NCM disease, which will be conducted in up to 40 locations across the United States.
"Given the urgent need to improve treatment options for patients with NTM, we welcome this fast track qualification and the regulatory support it provides, which will accelerate the ongoing RHB-204 Phase 3 development and any subsequent potential approvals," said Patricia Anderson, Senior Vice President of Regulatory Affairs at RedHill.
is fortunate that NTT is rare, but the prevalence of the disease is on the rise in many parts of the world.
is a well-known and incurable disease that, if left untreated, can cause scarring and fibrosis in the lungs, which can lead to respiratory failure.
many patients do not work after receiving current treatment, and more than half of them will relapse or develop new infections after completing treatment.
" under RedHill's expanded access policy RHB-204 may be eligible for use - see: for more details.
Phase 3 study, RHB-204, is registered as a web-based service at the National Institutes of Health to keep the public relevant about clinical research supported by the public and private sectors.
About Mycobacterium tuberculosis (NTM) is a chronic, debilitating lung disease caused by environmental bacteria ubiquitous in soil and natural and artificial water systems.
most common symptoms of NTM include fever, weight loss, chest pain, and blood in the sputum.
NTM disease in the lungs can lead to the recurrence of bronchitis and pneumonia and, in some cases, respiratory failure.
lung NPM disease, although rare, has increased in many parts of the world.
2017, the number of lung NPM patients in the U.S. is estimated at 110,000, and the U.S. market potential is valued at more than $500 million.
lungs account for 80-90% of all NTT-related diseases, and about 80% of lung NTT diseases are caused by mycobacteria compound (MAC) in birds.
about RHB-204 RHB-204 is a proprietary fixed-dose oral capsule containing a combination of clariamycin, lifobitin, and chlorpyrobacterium compositions for the treatment of lung NTT disease caused by mycobacterium compound group (MAC) in birds.
In addition to FDA fast-track eligibility, RHB-204 was granted FDA orphan drug eligibility for the treatment of NTT disease and was recognized by QIDP under the Encouraged Antibiotics Act, which allows RHB-204 to be extended to a total of 12 years in the U.S. market after FDA approval.
RHB-204 also received relevant U.S. patent protection, extending the patent period to 2029, and another U.S. patent is in the process of being approved, which, if approved, extends RHB-204 patent protection until 2041.
note: The original text has a cut-out reference: s1. Henkle E et al.
Patient-Centered Research Priorities for Pulmonary Nontuberculus Mycobacteria (NTM) Infection. (Patient-Centered Priority Study of Mycobacteria tuberculosis infection) An NTM Research Research Consortium Report Report (NTM Research Alliance Seminar Report) Annals of American Society 2016 (2016 Annual Report of the American Thoracic Society); S379-84。
Daley CL et al.
Treatment of Nontuberculus Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Practice: Executive Summary: Treatment of Non-TB Mycobacteria Lung Disease: ATS/ERS/ESCMID/IDSA Clinical Practice Guide: Executive Summary) Clinical Medical (Clinical Infectious Diseases) Ciaa241. [3] Kim RD et al. Pulmonary Nontuberculus Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome (Mycobacteria tuberculosis: a prospective study of an apparent pre-existing syndrome) American Journal of Respiratory and Intensive Care Medicine 2008; 178(10):1066–74. American Lung Association, 2020. [5] Henkle E et al.
Population-based Incidence of Pulmonary Nontuberculus Mycobacterial Disease in Oregon 2007 to 2012 (2007-2012 Oregon population-based incidence of mycobacteria tuberculosis) Annual Report of the American Thoracic Society. 12(5):642-7. [6] Foster| Rosenblatt, 2017. [7] Griffith DE et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases (ATS/IDSA Official Statement: Diagnosis, Treatment and Prevention of Non-TB Mycobacteria Disease) American Journal of Respiratory and Intensive Care Medicine. 2007; 175(4):367-416. [8] Prevots DR et al. Nontuberculus mycobacterial lung disease prevalence at four integrated health care delivery systems (prevalence of non-tuberculosis mycobacteria lung disease in four integrated health care systems) American Journal of Respiratory and Intensive Care Medicine 2010; 182:970-76; Winthrop KL et al. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. (Epidemic and clinical characteristics of mycobacteria tuberculosis: a new public health disease) American Journal of Respiratory and Intensive Care Medicine 2010; 182: 977-82