FDA Complete Response Letter
FDA Issues Complete Response Letter to Alimera Sciences Regarding New Drug Application for ILUVIEN(R
ATLANTA, Dec. 23, 2010 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq:ALIM - News) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational drug ILUVIEN(R).
The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.
The application seeks the approval to market ILUVIEN (fluocinolone acetonide intravitreal insert), Alimera's investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).
Alimera submitted the ILUVIEN NDA to the FDA on June 29, 2010 with safety and efficacy data through month 24 of the FAME Study.
The FDA granted the NDA Priority Review status on August 30, 2010.
No new clinical studies were requested in the CRL.
However, the FDA asked for analyses of the safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted to the FDA, to further assess the relative benefits and risks of ILUVIEN.
The NDA included data through month 24.
Alimera has completed month 36 of the study and is preparing the analyses the FDA requested.
The FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN, which Alimera is in the process of compiling.
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,
which were completed in August and September of 2010,
and that all facilities and controls will need to comply with cGMP. Alimera's third-party manufacturers are in the process of resolving these deficiencies.
"We appreciate the FDA's efforts to complete a Priority Review of our NDA and look forward to working closely with the FDA toward approval of ILUVIEN for the treatment of DME," said Dan Myers, president and chief executive officer of Alimera.
"To expedite the process, we have requested a meeting with the FDA to clarify the path to regulatory approval."
finance.yahoo.com |
