New PDUFA date for DME implant, PAS submitted

May 08, 2013

A new PDUFA goal date has been established with the FDA for Iluvien fluocinolone acetonide implant (Alimera Sciences Inc.), and a PAS has been submitted to NICE in the United Kingdom.

 

Atlanta-Alimera Sciences Inc. announces that its recent resubmission of the new drug application (NDA) for Iluvien has been acknowledged as received by the FDA as a complete class 2 response to the FDA’s November 2011 letter and that a new prescription drug user fee act (PDUFA) goal date of October 17, 2013 has been established.

Iluvien is a sustained-release intravitreal implant containing190 µg fluocinolone acetonide in applicator and is used to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

In the resubmission, Alimera responded to questions raised in the FDA’s letter and provided additional analyses as well as new information to support that the implant is safe and effective in the treatment of patients with chronic DME.

The resubmission focused on the safety aspects of the implant and the subgroup population of patients with chronic DME. Marketing approval for the implant has been granted in six countries in the European Union for the same subgroup.

“We believe this FDA resubmission package includes important new information that demonstrates the safety and efficacy of [the implant] for patients suffering from chronic DME,” said Dan Myers, Alimera’s president and chief executive officer. “We believe a clearer positioning now exists for Iluvien in the treatment of patients with chronic DME, since a first-line pharmacotherapy for DME was approved by the FDA last year.”

In other news, the company notes that Iluvien is now available in the United Kingdom, and that it has recently submitted a simple Patient Access Scheme (PAS) to the United Kingdom’s National Institute for Health and Care Excellence (NICE) for consideration of the guidance under rapid review. The NICE Appraisal Committee will assess the likely impact of the PAS and determine whether an update to NICE’s previously issued final guidance is warranted. If the PAS is accepted, it is anticipated that the implant would be funded in England and Wales through the National Health Service for patients with chronic DME.

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