![]() You do not even need to push a button! As soon as your car comes within reach of the garden gate or garage door. Opening the gate of your garden or garage door is done fully automatically by LaserTrack Flare. Protection of a laser gun being fired at your vehicle.Notification of a laser gun being fired at your vehicle.Activating your home’s security lighting.Details on this expanded access policy can be found here.Using leading-edge infrared laser technology, this robust remote control device, the LaserTrack Flare is perfect for opening security gates, garage doors and operating outdoor lights ensuring a safe, convenient and comfortable end to your drive. ![]() In the U.S., a physician must submit an individual request to the FDA for approval before the company can provide access to the therapy. ![]() The durability of microbiological response will also be evaluated three months after finishing treatment.Īccording to the release, RHB-204 may be eligible for use under RedHill’s expanded access policy, which provides certain patients access to its investigational therapies before regulatory approval. More information on contacts and locations can be found here.ĬleaR-MAC will assess whether RHB-204 is superior to a placebo at clearing MAC from patients’ sputum, improving their physical functioning, and lessening respiratory symptoms and fatigue. RedHill recently launched a Phase 3 clinical trial, called CleaR-MAC ( NCT04616924), that will evaluate the safety and effectiveness of RHB-204 against a placebo in up to 125 adults with non-cystic fibrosis bronchiectasis and MAC lung infection.Įligible patients, to be recruited at up to 40 sites across the U.S., must not yet have been treated for MAC, or at least not within the six months prior to enrollment. It is said by the company to have potent intracellular, anti-mycobacterial, and anti-inflammatory properties. RHB-204 is a fixed-dose, oral capsule with a combination of clarithromycin, rifabutin, and clofazimine. ![]() About 110,000 people were estimated to have NTM lung disease in the U.S. “It is a notoriously difficult to treat disease and, if not effectively treated, can cause scarring … in the lungs - potentially leading to respiratory failure,” Anderson said, adding that “many patients fail current therapies, and more than half will have either recurring disease or a new infection after completing treatment.”Ĭurrently, there is no FDA-approved first-line therapy for NTM lung infections, whose “prevalence is increasing in many areas of the world,” Anderson said. People with bronchiectasis are at increased risk of developing lung infections caused by NTM, which are considered therapeutically challenging, often becoming chronic. MAC is the most common cause of NTM lung infection in humans. NTM are a set of more than 160 species of bacteria found naturally in the environment. marketing exclusivity period of 12 years. RHB-204 previously was given FDA qualified infectious disease product and orphan drug status to treat NTM infections, providing further support and possible benefits, including a potential for priority review and accelerated approval, as well as a U.S. “Given the urgent need to improve therapeutic options for patients with NTM disease, we welcome this Fast Track designation and the regulatory support it provides in expediting the ongoing Phase 3 development program for RHB-204 and any subsequent potential approvals,” Patricia Anderson, the senior vice president of RedHill’s regulatory affairs, said in a press release. Rolling review means that the company can submit sections of the regulatory application for review as they come ready, rather than waiting for every section to be completed before the application can be reviewed by the agency. It is meant to speed their clinical development, regulatory review - enabling a rolling review - and, if approved, their entry into the market. This designation is given to therapies that show considerable potential in addressing serious conditions for which available treatments fall short. Food and Drug Administration (FDA) has given fast track designation to RedHill Biopharma’s RHB-204 as a potential first-line and stand-alone, oral treatment for lung infections caused by Mycobacterium avium complex (MAC), a type of non-tuberculous mycobacteria (NTM).
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