Insmed Announces FDA Acceptance for Filing of New Drug Application for ALIS in NTM Lung Disease Caused by MAC

- May 16th, 2018

Insmed (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) has been … Continued

Insmed (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) has been accepted and will be considered filed on May 27, 2018.

As quoted in the press release:

The FDA has completed the filing review and determined that the application is sufficiently complete to permit a substantive review.  The FDA granted Insmed’s request for Priority Review and has set an action date of September 28, 2018 under the Prescription Drug User Fee Act (PDUFA).

“We are pleased that the FDA has accepted our NDA with Priority Review, which underscores the urgent need for therapies which address NTM lung disease caused by MAC,” said Will Lewis, President and Chief Executive Officer of Insmed. “ALIS has the potential to be the first approved inhaled therapy for the treatment of this serious and debilitating lung infection in the United States, and we look forward to working with the Agency through the review process.”

Click here to read the full press release.

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