pSivida partner gets new PDUFA date
pSivida (ASX:PVA) licensee Alimera Sciences will know by late September whether the US FDA has approved the company’s fourth new drug application for diabetic macular edema (DME) treatment Iluvien.
The regulator has set a new Prescription Drug User Fee Act (PDUFA) date - the target date for the agency to make its decision on the application - of 26 September.
Iluvien, which uses a micro-insert designed by pSivida, has been approved in Europe and is available in the UK and Germany. But the FDA has repeatedly knocked back Alimera’s NDAs for the product.
Alimera filed its fourth NDA in late March, five months after the FDA issued a complete response letter covering the third application.
In a statement, pSivida said the fourth submission addressed the questions raised in the FDA’s latest letter and provides data from Iluvien patients and physician experiences in the UK and Germany.
“We are pleased to have the PDUFA goal date set for Iluvien and look forward to the FDA’s action on the resubmitted NDA,” pSivida CEO Paul Ashton said.
pSivida is independently seeking to commercialise a treatment for posterior uveitis using the same micro-insert as Iluvien, and commenced phase III trials in mid-2013. FDA approval for Iluvien would help ease the approval process for the uveitis treatment.
pSivida (ASX:PVA) shares were trading unchanged at $4.00 as of around 1.30 pm on Tuesday
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