Inspection Delay Puts Back Hanmi/Spectrum’s Rolontis
US Action Date Now Set For Feb '21
US FDA defers action on Spectrum’s approval application for neutropenia candidate Rolontis due to pandemic-related difficulties inspecting partner Hanmi’s plant. The action date has been put back although the companies stress no CRL has been issued.
You may also be interested in...
This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.
Hanmi’s novel, long-acting neutropenia drug gets world-first approval in South Korea, setting it up to be the first product using the company's proprietary platform technology to be commercialized. An FDA manufacturing inspection also seems to bode well for the pending US approval.
Hanmi partner Athenex has had a US complete response letter for its oral paclitaxel plus encequidar product for the treatment of metastatic breast cancer, amid concerns of safety risks associated with an increase in neutropenia-related sequelae. While the decision marks another setback for Hanmi in the US, Athenex is aiming to resolve the issues.