trending Market Intelligence /marketintelligence/en/news-insights/trending/ouafh8vazf9gnupbsmsgia2 content esgSubNav
In This List

MiMedx's arthritis drug receives US FDA designation for regenerative medicine

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


MiMedx's arthritis drug receives US FDA designation for regenerative medicine

MiMedx Group Inc.'s AmnioFix injectable received the U.S. Food and Drug Administration's regenerative medicine advanced therapy designation for treating osteoarthritis of the knee, which occurs due to the breakdown of cartilage in the knee that leaves the bone beneath exposed.

The FDA stated that the Marietta, Ga.-based biopharmaceutical company's drug has the potential to address unmet medical needs for this condition.

MiMedx said the U.S. regulator will meet the company to discuss, among other things, plans to expedite developing and manufacturing the medicine.

An investigational therapy is eligible for the regenerative medicine advanced therapy designation if it is intended to treat, modify, reverse or cure a serious condition, and if preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for the condition.

The designation includes the benefits of the FDA's fast-track and breakthrough therapy designation programs, including early interaction with sponsors, which may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval.