Apnimed Granted FDA Fast Track Designation for AD109, a Novel First-in-Class Oral Pharmacologic Combination for the Treatment of Obstructive Sleep Apnea (OSA)

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral pharmacologic AD109 for the treatment of OSA.

“Fast Track designation is a significant milestone in the development of AD109 and provides an accelerated regulatory pathway that recognizes the urgent need for new pharmacologic treatments for OSA that are easier for people to tolerate,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “Currently the vast majority of more than 35 million Americans who have OSA remain untreated despite the potential for serious health risks associated with the condition, including cardiovascular disease and diabetes. We will continue to work closely with the FDA to support the development and review of AD109 beginning with the trial design for our Phase 3 program, which we anticipate initiating at the end of 2022.”

FDA’s Fast Track designation is intended to facilitate the development and expedite the review of new drugs to treat serious conditions and that fill an unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss development plans, trial design, and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met.

Click here to read the full article at BusinessWire

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.