Santhera's clinical data are in, but NDA delayed 4-6 months by third party manufacturer
Santhera Pharmaceuticals finished submitting the clinical portion of its rolling NDA yesterday, but the Swiss biotech’s regulatory ambitions are now pushed back four to six months because of manufacturing hurdles.
The biotech said its third-party contract manufacturer needs up to half a year to get ready for FDA inspections, Santhera disclosed Wednesday.
Santhera started submitting documents to the FDA in March for its drug vamorolone, which it hopes will get the green light for treating Duchenne muscular dystrophy. CEO Dario Eklund told Endpoints News earlier this month that the company was hoping for a PDUFA date in Q1 or Q2 of next year.
Eklund had said in the first days of June that Santhera was hoping for the FDA to consider the filing complete and accepted for review by the end of August or early September.
Now, the biotech will have to discuss with the regulator new timelines by the fourth quarter, Santhera said.
The drug in question passed a Phase IIb last year and was originally developed by ReveraGen. That private biotech had developed vamorolone as a dissociative steroid.
Santhera was on tap to pay out a $50 million milestone payment to ReveraGen, should the drug get approved, but the companies modified the deal earlier this month to $26 million, and $4 million prior to an FDA nod.
Vamorolone has fast track designation, orphan drug status and a rare pediatric disease tag from the FDA.
The company is also working on a path to approval in the EU, Santhera said Wednesday, noting that filing is “proceeding according to plan.”