FDA News

FDA grants fast track designation to cell therapy for degenerative disk disease

The FDA has given its fast track designation to the investigational cell therapy IDCT for the treatment of degenerative disc disease.

IDCT (DiscGenics) is an allogeneic injectable cell therapy derived from engineered progenitor cells. The engineered cells are produced using DiscGenics’ propriety Discogenic Cell platform and are derived from intervertebral disc tissue.

IDCT is given as a single percutaneous injection into the disc and is intended as a regenerative therapy for the pain and disability associated with DDD, which is a major cause of lower back pain.

“We are thrilled to receive fast track designation for IDCT as it recognizes the extremely compelling preclinical and safety data we have generated for IDCT through our robust research and development and clinical programs, and underscores FDA’s acknowledgement of low back pain as a serious medical condition with a profound lack of treatment options,” Flagg Flanagan, chairman and CEO of DiscGenics, said in a press release.

“This Fast Track designation reinforces our commitment to working with regulators to identify ways to accelerate development and expedite approval of the therapy within existing regulatory frameworks to make IDCT available to patients as quickly as possible,” he added.

The FDA's fast track designation helps to expedite drug development, review and potential approval.

IDCT is currently being evaluated in two multicenter, randomized clinical trials in the United States and Japan. Preliminary safety findings for the investigational cell therapy were published in January 2019 and showed that no treatment-related adverse effects occurred among the 10 patients enrolled in the U.S.-based study (maximum follow-up, 6 months).

Reference:

DiscGenics. DiscGenics receives FDA Fast Track Designation for cell therapy for disc degeneration. August 26, 2019. Available at: www.discgenics.com/news-posts/2019/8/26/discgenics-receives-fda-fast-track-designation-for-cell-therapy-for-disc-degeneration. Accessed August 27, 2019.

The FDA has given its fast track designation to the investigational cell therapy IDCT for the treatment of degenerative disc disease.

IDCT (DiscGenics) is an allogeneic injectable cell therapy derived from engineered progenitor cells. The engineered cells are produced using DiscGenics’ propriety Discogenic Cell platform and are derived from intervertebral disc tissue.

IDCT is given as a single percutaneous injection into the disc and is intended as a regenerative therapy for the pain and disability associated with DDD, which is a major cause of lower back pain.

“We are thrilled to receive fast track designation for IDCT as it recognizes the extremely compelling preclinical and safety data we have generated for IDCT through our robust research and development and clinical programs, and underscores FDA’s acknowledgement of low back pain as a serious medical condition with a profound lack of treatment options,” Flagg Flanagan, chairman and CEO of DiscGenics, said in a press release.

“This Fast Track designation reinforces our commitment to working with regulators to identify ways to accelerate development and expedite approval of the therapy within existing regulatory frameworks to make IDCT available to patients as quickly as possible,” he added.

The FDA's fast track designation helps to expedite drug development, review and potential approval.

IDCT is currently being evaluated in two multicenter, randomized clinical trials in the United States and Japan. Preliminary safety findings for the investigational cell therapy were published in January 2019 and showed that no treatment-related adverse effects occurred among the 10 patients enrolled in the U.S.-based study (maximum follow-up, 6 months).

Reference:

DiscGenics. DiscGenics receives FDA Fast Track Designation for cell therapy for disc degeneration. August 26, 2019. Available at: www.discgenics.com/news-posts/2019/8/26/discgenics-receives-fda-fast-track-designation-for-cell-therapy-for-disc-degeneration. Accessed August 27, 2019.