Amikacin Sulfate

FDA has completed its review of the rationale document titled, “Aminoglycoside Breakpoints for Enterobacterales and Pseudomonas aeruginosa ” submitted by the Clinical and Laboratory Standards Institute (CLSI) to the public docket FDA-2017-N-5925-0037 in January 2025. 1 Gentamicin, tobramycin, and amikacin are aminoglycoside antibacterial drugs approved for the treatment of serious infections including those caused by P. aeruginosa and several Enterobacterales species. In March 2023, the Clinical and Laboratory Standards Institute (CLSI) published revised breakpoints for gentamicin, tobramycin, and amikacin against Enterobacterales and P. aeruginosa in their M100-Ed 33 supplement. For Enterobacterales CLSI lowered the gentamicin, tobramycin, and amikacin breakpoints (Table 1). For P. aeruginosa , CLSI removed the gentamicin breakpoints, lowered the tobramycin breakpoints, and left the amikacin breakpoints numerically unchanged but limited their applicability to urinary isolates only (Table 2). Table 1. Historical a and Current b CLSI Gentamicin, Tobramycin, and Amikacin Breakpoints against Enterobacterales Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (zone diameter in mm) S I R S I R Gentamicin Historical ≤ 4 8^ ≥ 16 ≥ 15 13 - 14^ ≤ 12 Current ≤ 2 4^ ≥ 8 ≥ 18 15 - 17^ ≤ 14 Tobramycin Historical ≤ 4 8^ ≥ 16 ≥ 15 13 - 14^ ≤ 12 Current ≤ 2 4^ ≥ 8 ≥ 17 13 - 16^ ≤ 12 Amikacin Historical ≤ 16 32^ ≥ 64 ≥ 17 15 - 16^ ≤ 14 Current ≤ 4 8^ ≥ 16 ≥ 20 17 - 19^ ≤ 16 S = Susceptible; I = Intermediate; R = Resistant; MIC = minimum inhibitory concentration ^, designation for agents that have the potential to concentrate in the urine a These breakpoints have been recognized by FDA. b First published in CLSI M100-Ed33, March 2023. Table 2. Historical a and Current b CLSI Gentamicin, Tobramycin, and Amikacin Breakpoints against Pseudomonas aeruginosa Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (zone diameter in mm) S I R S I R Gentamicin Historical ≤ 4 8^ ≥ 16 ≥ 15 13 - 14^ ≤ 12 Current - - - - - - Tobramycin Historical ≤ 4 8^ ≥ 16 ≥ 15 13 - 14^ ≤ 12 Current ≤ 1 2^ ≥ 4 ≥ 19 13 - 18^ ≤ 12 Amikacin Historical ≤ 16 32^ ≥ 64 ≥ 17 15 - 16^ ≤ 14 Current (U) c ≤ 16 32^ ≥ 64 ≥ 17 15 - 16^ ≤ 14 S = Susceptible; I = Intermediate; R = Resistant; MIC = minimum inhibitory concentration ^, designation for agents that have the potential to concentrate in the urine a These breakpoints have been recognized by FDA. b First published in CLSI M100-Ed33, March 2023. c (U) for reporting on urinary isolates only The dosing regimens that were used to establish the CLSI breakpoints include 7 mg/kg intravenously (IV) every 24 hours for gentamicin and tobramycin, and 15 mg/kg IV every 24 hours for amikacin. To minimize dissection of the wild-type bacterial population and preserve reproducibility of susceptibility testing, CLSI used the net bacterial stasis endpoint in the probability of target attainment (PTA) analyses because 1-log colony-forming unit (CFU) reduction was not attainable for MICs representing the high end of the wild-type population, i.e., the epidemiological cutoff MIC. Moreover, for P. aeruginosa and gentamicin and amikacin, even the net stasis endpoint was not attainable for a large segment of the wild population. Consequently, CLSI eliminated the gentamicin breakpoints against P. aeruginosa . Amikacin breakpoints for P. aeruginosa were retained but limited to urinary isolates only on the basis that amikacin concentrates in the urine and that clinical efficacy data demonstrate that favorable outcomes are most reliable for infections originating in the urinary tract. FDA acknowledges the limitations of the data but agrees that the revised breakpoints would be more predictive of clinical outcomes as compared to the currently recognized FDA breakpoints, and therefore, recognizes the CLSI gentamicin, tobramycin, and amikacin breakpoints for Enterobacterales and P. aeruginosa as displayed above. 1 Comment from Clinical and Laboratory Standards Institute (CLSI) Content current as of: 10/23/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

BRIDGEWATER, N.J., June 11, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it priced an underwritten public offering of 7,812,500 shares of its common stock at a price to the public of $96.00 per share. The gross proceeds to Insmed from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, are expected to be approximately $750 million. In addition, Insmed has granted the underwriters a 30-day option to purchase up to an additional 1,171,875 shares of common stock. Insmed intends to use the net proceeds from this offering to fund continued research and development of brensocatib as well as pre-commercial and, if approved, commercialization activities related to brensocatib, activities related to the further commercialization and development of ARIKAYCE® (amikacin liposome inhalation suspension), further research and development of treprostinil palmitil inhalation powder (TPIP), INS1201, and the Company's pre-clinical research product candidates, and for other general corporate purposes, including business expansion activities. Goldman Sachs & Co. LLC, Leerink Partners, BofA Securities, Jefferies and J.P. Morgan are acting as joint book-running managers for the offering. Stifel is acting as co-lead manager for the offering. The offering is expected to close on June 13, 2025, subject to the satisfaction of customary closing conditions. The public offering of common stock described above is being made pursuant to Insmed's shelf registration statement on Form S-3 (File No. 333-272088) that was previously filed with the Securities and Exchange Commission (SEC) and became automatically effective on May 19, 2023. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC's website at . Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected] or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering; failure to continue to successfully commercialize ARIKAYCE, our only approved product, in the United States ("U.S."), Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; our inability to obtain full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for brensocatib, TPIP or our other product candidates in the U.S., Europe or Japan or for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage; failure to successfully commercialize brensocatib, TPIP or our other product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for brensocatib, TPIP or our other product candidates, if approved; uncertainties or changes in the degree of market acceptance of ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates, or acceptable prices for ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates; inaccuracies in our estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP, or our other product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE, brensocatib, or TPIP for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business; the risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP, or our other product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates or to permit the use of ARIKAYCE in the broader population of patients with Mycobacterium avium complex lung disease, among other things; development of unexpected safety or efficacy concerns related to ARIKAYCE, brensocatib, TPIP, or our other product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; the risk that the full data set from the TPIP study in pulmonary arterial hypertension ("PAH") or data generated in further clinical trials of TPIP will not be consistent with the topline results of the TPIP PAH study; risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management's time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology; risk that we are unable to maintain our significant customers; risk that government healthcare reform materially increases our costs and damages our financial condition; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; risk that our current and potential future use of artificial intelligence and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; the risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by agreements related to ARIKAYCE, brensocatib or our other product candidates, including our license agreements with PARI Pharma GmbH and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; our limited experience operating internationally; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent Company filings with the SEC. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Bryan Dunn Vice President, Investor Relations (646) 812-4030 [email protected] Media: Claire Mulhearn Vice President, Corporate Communications (862) 842-6819 [email protected] SOURCE Insmed Incorporated WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED