An NDA was submitted for oral semaglutide seeking approval for an indication for the treatment of adults with type 2 diabetes. A priority review voucher (“PRV”) has been applied to the NDA, leading to an anticipated review time of six months from the submission date, according to standard
A second NDA was submitted for oral semaglutide seeking approval for a cardiovascular (“CV”) risk reduction indication in adults with type 2 diabetes. The NDA for an oral semaglutide cardiovascular risk reduction indication has an anticipated 10-month review time from the submission date, according to standard
A copy of Novo Nordisk’s announcement can be viewed at the following link:
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company’s development activities and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the Company’s business development activities. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors, including, but not limited to, the sufficiency of Emisphere’s cash position, the success of our and our partner’s development and commercialization efforts, and our ability to successfully partner our Eligen® Technology.
Source: Emisphere Technologies, Inc.