31 January 2018 - - The US Food and Drug Administration has accepted for review the new drug application for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist, recently submitted by Dublin, Ireland-based biopharmaceutical company Theravance Biopharma, Inc. (NASDAQ: TBPH) and its strategic collaboration partner Mylan N.V. (NASDAQ, TASE: MYL), the company said.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 13, 2018, and indicated that it does not currently plan to convene an advisory committee meeting to discuss the NDA.
Revefenacin (TD-4208) is a novel investigational once-daily nebulized LAMA under FDA review for the treatment of moderate to very severe COPD.
Theravance Biopharma and its affiliates have partnered with Mylan and its affiliates on the development and commercialization of nebulized revefenacin products for COPD and other respiratory diseases.
Theravance Biopharma's pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions, primarily in the acute care setting.
The company's research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and intestinal tract in order to maximize patient benefit and minimize risk.