FDA NEWS
FDA grants regenerative medicine advanced therapy designation to injectable treatment for knee OA
March 12, 2018
https://www.healio.com/orthopedics/arthritis/news/online/{590dabc8-992a-45b4-9147-ce9f9a4fd24b}/fda-grants-regenerative-medicine-advanced-therapy-designation-to-injectable-treatment-for-knee-oa
MiMedx Group Inc. announced the FDA has granted the regenerative medicine advanced therapy designation to the company’s AmnioFix Injectable for use in the treatment of osteoarthritis of the knee.
Along with confirmation that MiMedx’s allogeneic micronized dehydrated human amnion/chorion membrane (micronized dHACM) for the treatment of OA of the knee meets the criteria for regenerative medicine advanced therapy (RMAT) designation, the FDA also committed to a multidisciplinary comprehensive discussion with MiMedx regarding a development program, according to a company press release. This includes planned clinical trials and plans for expediting the manufacturing development strategy, the release noted. MiMedx added the FDA will provide intensive guidance on efficient drug development and an organizational commitment to involve senior management in facilitating the development program for the product.
“The FDA’s RMAT designation for AmnioFix Injectable is an important milestone for MiMedx and highlights the importance of introducing promising therapies in areas of considerable unmet medical need,” Parker H. “Pete” Petit, chairman and CEO of MiMedx, said in the release. “We are especially pleased that the FDA will meet to discuss expediting our development and manufacturing of this product to serve the needs of patients suffering from OA of the knee. We look forward to discussions with the FDA.”
Reference:
http://phx.corporate-ir.net/phoenix.zhtml?c=213465&p=irol-newsArticle&ID=2337351
FDA grants regenerative medicine advanced therapy designation to injectable treatment for knee OA
March 12, 2018
https://www.healio.com/orthopedics/arthritis/news/online/{590dabc8-992a-45b4-9147-ce9f9a4fd24b}/fda-grants-regenerative-medicine-advanced-therapy-designation-to-injectable-treatment-for-knee-oa
MiMedx Group Inc. announced the FDA has granted the regenerative medicine advanced therapy designation to the company’s AmnioFix Injectable for use in the treatment of osteoarthritis of the knee.
Along with confirmation that MiMedx’s allogeneic micronized dehydrated human amnion/chorion membrane (micronized dHACM) for the treatment of OA of the knee meets the criteria for regenerative medicine advanced therapy (RMAT) designation, the FDA also committed to a multidisciplinary comprehensive discussion with MiMedx regarding a development program, according to a company press release. This includes planned clinical trials and plans for expediting the manufacturing development strategy, the release noted. MiMedx added the FDA will provide intensive guidance on efficient drug development and an organizational commitment to involve senior management in facilitating the development program for the product.
“The FDA’s RMAT designation for AmnioFix Injectable is an important milestone for MiMedx and highlights the importance of introducing promising therapies in areas of considerable unmet medical need,” Parker H. “Pete” Petit, chairman and CEO of MiMedx, said in the release. “We are especially pleased that the FDA will meet to discuss expediting our development and manufacturing of this product to serve the needs of patients suffering from OA of the knee. We look forward to discussions with the FDA.”
Reference:
http://phx.corporate-ir.net/phoenix.zhtml?c=213465&p=irol-newsArticle&ID=2337351