Orphazyme has asked for more time to address late-stage issues that the European Medicines Agency has about its EU marketing authorization application (MAA) for arimoclomol, an investigational treatment for the rare, genetic, progressively debilitating and often fatal Niemann-Pick disease type C.
The Danish company’s request to the EMA’s human medicines evaluation committee (the CHMP) for additional time comes months after arimoclomol was rejected by US regulators for the same indication, citing the need for additional data
Clock Stops During CHMP Evaluation
The standard assessment of a marketing authorization application (MAA) for a new medicine at the European Medicines Agency takes up to 210 ‘active’ days. This time may be interrupted by one or two “clock-stops” during which the sponsor prepares responses to any questions raised by the EMA's drug evaluation committee, the CHMP.
The maximum duration of a clock-stop depends on how long the company thinks it will take to respond but must be agreed by the CHMP. The first clock-stop usually lasts three to six months and the second clock-stop one to three months.
The first clock stop usually takes place at Day 120 of the evaluation process, while the company prepares responses to the CHMP’s “list of questions” and updates the medicine’s risk management plan
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?
