Insmed Incorporated Provides Update on ARIKAYCE(R) (Amikacin Liposome Inhalation Suspension) U.S. Launch and Outlines Strategic Priorities for 2019
January 05, 2019 at 02:36 am IST
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Insmed Incorporated provided an update on the U.S. launch of ARIKAYCE(R) (amikacin liposome inhalation suspension). ARIKAYCE was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on September 28, 2018, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. As of December 31, 2018, more than 500 patients in the U.S. have initiated treatment with ARIKAYCE and approximately 600 physicians in the U.S have written at least one prescription for the therapy. Insmed has established the strategic priorities for 2019: Continue its efforts to ensure a U.S. launch of ARIKAYCE. Complete the design and protocol of the confirmatory clinical study during the first half of 2019 required for the full approval of ARIKAYCE by the FDA in the U.S in a front-line setting of patients with MAC lung disease. Accelerate its global expansion to support potential regulatory filings for ARIKAYCE in Europe in mid-2019 and in Japan in the first half of 2020. Advance pipeline, which is intended to bring additional therapies to market for patients with serious and rare diseases, including completing enrollment in the WILLOW study, its six-month Phase 2 trial of INS1007 in patients with non-cystic fibrosis bronchiectasis, in mid-2019.
Insmed Incorporated is a global biopharmaceutical company. The Company's first commercial product, ARIKAYCE (amikacin liposome inhalation suspension), is used for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. Its pipeline includes clinical-stage programs, brensocatib and TPIP, as well as other early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), which is developing for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases, including chronic rhinosinusitis without nasal polyps (CRSsNP). TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil, which offers a differentiated product profile for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).