Orphazyme Provides an Update on its New Drug Application to the FDA
Feb 11, 2022 By MarketDepth
Orphazyme A/S (NASDAQ: ORPH) provided an update on the process and anticipated timelines for resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration.
Up Over 12%
Shares of Orphazyme A/S (NASDAQ: ORPH) gained over 12% in premarket trading.
“Requesting a Type C Meeting is the next step in establishing a potential path to resubmission of our NDA to the FDA. NPC is a rare neurodegenerative disease for which there are no approved treatments in the United States, and we look forward to continuing our interactions with the Agency as we seek to gain approval of arimoclomol in the United States for this devastating disease.”Anders Vadsholt, Chief Financial Officer of Orphazyme
The company had already submitted the EU Marketing Authorisation Application with the European Medicines Agency (EMA) in November 2020 and now intends to request a Type C Meeting to discuss the additional data, information, and analyses addressing certain topics in the Complete Response Letter (CRL) to align on a path to resubmission for arimoclomol in NPC with the FDA, according to the press release.
Subject to these discussions, the Company aims to resubmit the NDA during the second half of 2022.