Following up the good news released at the recent ARVO Meeting (Iluvien Update 2: New Safety and Efficacy Data Presented at ARVO), Alimera Sciences Inc. filed a resubmission of its New Drug Application (NDA) for the use of Iluvien in treating diabetic macular edema (DME). This resubmission addresses the questions raised in the Complete Response Letter (CRL) received in December 2010. (See Iluvien Update: FDA Marketing Approval Delayed)
As noted by Alimera, according to the FDA's classification, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission is received by the FDA.
This resubmission addresses the FDA's request for further analyses of the safety and efficacy data through month 36 of Alimera's FAME Study, and includes the data from the subgroup population that was presented last week at the ARVO Meeting. In addition, the resubmission includes further information regarding controls and specifications about the manufacturing, packaging and sterilization of Iluvien, which was requested by the FDA.
"We believe that the resubmission package sent to the FDA will demonstrate the safety and efficacy of Iluvien and address the FDA's additional issues," said Dan Myers, Alimera's president and CEO. "We look forward to working with the FDA for a prompt review and response."
In the CRL, the FDA also indicated that it had observed deficiencies in current good manufacturing practices (cGMP) during its facility inspections of two of Alimera's third-party manufacturers. Alimera believes the deficiencies have been resolved and no further action is required because the FDA has issued letters to both of these third-party manufacturers indicating that the inspections are now closed.
"We look forward to the FDA's response to Alimera's resubmission of the NDA for Iluvien for DME, which if approved, would be our third FDA-approved product," said Dr. Paul Ashton, President and Chief Executive Officer of pSivida. "We are also working on several earlier stage technologies including bioerodible systems to deliver proteins and small drug molecules for macular degeneration and glaucoma." (pSivida licenses the Iluvien delivery system to Alimera.)
Upon approval of Iluvien, pSivida is entitled to receive a $25 million milestone payment from Alimera and 20 percent of net profits, as defined, on sales of the drug made by Alimera.
As noted by Alimera, according to the FDA's classification, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission is received by the FDA.
This resubmission addresses the FDA's request for further analyses of the safety and efficacy data through month 36 of Alimera's FAME Study, and includes the data from the subgroup population that was presented last week at the ARVO Meeting. In addition, the resubmission includes further information regarding controls and specifications about the manufacturing, packaging and sterilization of Iluvien, which was requested by the FDA.
"We believe that the resubmission package sent to the FDA will demonstrate the safety and efficacy of Iluvien and address the FDA's additional issues," said Dan Myers, Alimera's president and CEO. "We look forward to working with the FDA for a prompt review and response."
In the CRL, the FDA also indicated that it had observed deficiencies in current good manufacturing practices (cGMP) during its facility inspections of two of Alimera's third-party manufacturers. Alimera believes the deficiencies have been resolved and no further action is required because the FDA has issued letters to both of these third-party manufacturers indicating that the inspections are now closed.
"We look forward to the FDA's response to Alimera's resubmission of the NDA for Iluvien for DME, which if approved, would be our third FDA-approved product," said Dr. Paul Ashton, President and Chief Executive Officer of pSivida. "We are also working on several earlier stage technologies including bioerodible systems to deliver proteins and small drug molecules for macular degeneration and glaucoma." (pSivida licenses the Iluvien delivery system to Alimera.)
Upon approval of Iluvien, pSivida is entitled to receive a $25 million milestone payment from Alimera and 20 percent of net profits, as defined, on sales of the drug made by Alimera.
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