FDA extends target date for review of Callidita’s drug candidate Nefecon (Finwire)
The US Food and Drug Administration (FDA) has requested more information from Calliditas and extended the target date for the drug candidate Nefecon in the United States. This is stated in a press release from the company.
Calliditas applied for an accelerated FDA approval, NDA, for the drug in March based on data from patients in its Nefigard study.
In its review, the FDA has requested additional study data from Nefigard, which has been submitted to the Swedish Medicines Agency. The FDA sees this as a significant update of the application but has due to this extended the target date for its decision to 15 December.
Ei tullut lottovoittoa, eikä myöskään isoa pettymystä. Nyt kun tölkkiä potkitaan taas eteenpäin, niin luvassa taitaa olla laskua tänään.