Hier die Meldung von GlobeNews. Also wird es noch eine kleine Weile dauern, bis das Approval
kommt. Die sprechen von einigen wenigen Wochen. Zur Wirksamkeit und Zusammensetzung keine Defizite von der FDA. "Nur" Fragen zur Herstellung/Verpackung/Labeling.
IntelGenx and RedHill Biopharma Receive Complete Response Letter From FDA for VersaFilm(TM) Oral Film Product for Acute Migraines
GlobeNewswire IntelGenx Corp.
56 minutes ago
FDA's letter accepted the bioequivalence study and safety information submitted and requires no additional clinical studies; IntelGenx and RedHill plan to address remaining issues, primarily related to third party manufacturing, packaging and labeling, within weeks based on available data
In light of the increased regulatory clarity, IntelGenx and RedHill plan to rapidly advance ongoing discussions with potential partners for the commercialization of their Anti-Migraine "VersaFilm(TM)" Oral Film Product
In addition to pursuing marketing approval in the U.S., IntelGenx and RedHill plan to complete the development program for the European market and submit a Marketing Authorization Application later this year
SAINT LAURENT, Quebec, Feb. 4, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, and RedHill Biopharma Ltd. (RDHL) (RDHL) ("RedHill"), an Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage drugs, today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for their VersaFilm(TM) Oral Film Product for the treatment of acute migraines. The VersaFilm(TM) product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt(R).
A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm(TM) product primarily relate to third party Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies.
While continuing to review the FDA's CRL, IntelGenx and RedHill believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks.
IntelGenx and RedHill have been in active discussions with potential partners for the commercialization of the product and expect to advance these discussions rapidly following FDA's CRL, which provides increased regulatory clarity, indicates that no further clinical trials are required, and raises no issues regarding to the product's safety.
"We appreciate the thorough review of the product NDA by the FDA. We remain committed to bringing the product to market as quickly as possible and will work closely with the FDA to advance the application and address all questions raised by the FDA," said Rajiv Khosla, IntelGenx' President and CEO and Dror Ben-Asher, RedHill's CEO in a joint statement. "We believe that the questions raised by the FDA can be addressed based on available data, and we plan to work vigorously to submit our response within a few weeks in order to bring this product to market as a new therapeutic option for the benefit of patients suffering from migraines."
In addition to pursuing marketing approval in the U.S., and following a positive meeting with the German pharmaceuticals regulation authority "BfArM" in October 2013, IntelGenx and RedHill plan to complete the development program for the European market and submit a Marketing Authorization Application for marketing approval of the product in Europe later this year, with Germany as the reference member state under the European Mutual Recognition Procedure. |
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