Amikacin Glean Breakthrough Therapy Status

Amikacin Glean Breakthrough Therapy Status

Amikacin CAS 37517-28-5 Breakthrough Therapy StatusThe end of June 2014 brought exciting news for Insmed’s liposomal Amikacin, known as the brand name Arikace, with a Breakthrough Status award from the FDA. Amikacin was specifically designated Breakthrough Status for treatment refractory nontuberculous mycobacterial lung disease in adult patients. As an inhaled antibiotic Amikacin is effectual for treating chronic nontuberculous mycobacterial lung disease, a condition which effects roughly 50,000 people in the United States. Amikacin {Arikace} is commencing Phase III development after positive results emerged from Phase II clinical trials.

Amikacin has proven to be a formidable opponent for fighting the Pseudomonas aeruginosa bacterium in patients with cystic fibrosis in Phase II trials. Patients with cystic fibrosis who received a once daily dose of Amikacin via an inhaled nebulizer system for 28 consecutive days demonstrated a superior clinical benefit as compared to a placebo. Additionally, patients tolerated Amikacin quite well and showed a sustained improvement in lung function as well as a reduction in the density of their Pseudomonas. Amikacin proved sustenance and efficacy in multiple cycles of treatments with additional patients too, in a successful long term open label study. These outstanding results have led study investigators to believe Amikacin will be equally effective in treating patients with chronic Pseudomonas lung infections.

Amikacin is currently administered to patients via Arikace, through an advanced pulmonary liposome technology that prolongs the release of Amikacin in the lungs. This inhaled formula is safe and tolerable as it minimizes systemic exposure. The ease of use and convenient dispensing makes this novel form of Amikacin an optimal choice for physicians treating patients with nontuberculous mycobacteria lung disease. Current treatment options for this chronic and debilitating lung disease involve multiple drugs for longer periods of time which have unfortunate adverse effects. Arikace {Amikacin} has been granted orphan drug status by the FDA and the European Medicines Agency for the treatment of Pseudomonas infections in patients who are suffering from cystic fibrosis. The FDA has also given Arikace orphan drug status to treat bronchiectasis in patients with either Pseudomonas or other susceptible pathogens.

LGM Pharma is a provider of API Amikacin CAS# 37517-28-5 and Amikacin Sulfate CAS# 37517-28-5, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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