Investing.com -- Dr. Laura Niklason, President and CEO of Humacyte, Inc. (NASDAQ: HUMA ), responded to a New York Times (NYSE: NYT ) article that questioned the FDA’s approval of Symvess for commercial sales earlier this week. Niklason had previously withheld comment due to the company being in a quiet period while finalizing a new round of financing.

The FDA’s review of the Biologics License Application (BLA) for Symvess, a process that took over a year, was highlighted by Niklason. During this period, the FDA considered convening an Advisory Committee of outside experts after Dr. Robert E. Lee, a consultant on the file, raised concerns. However, the FDA decided against this, instead opting for extensive internal consultation and seeking perspectives from three experienced vascular surgeons outside the agency.

Despite the original Prescription Drug User Fee Act (PDUFA) date being August 10, 2024, the FDA took an additional 19 weeks to complete its review of Symvess. After considering all views, the FDA approved Symvess on December 19, 2024, deeming it safe and effective for use in repair of vascular trauma of the extremities when autologous vein grafting is not feasible.

Niklason praised the FDA’s review process, noting that it was conservative and time-consuming, as it should be. She also disclosed that Humacyte is committed to conducting a post-approval study to further assess the rate and severity of adverse events in trauma patients treated with Symvess. The company remains confident that this study will confirm the safety and effectiveness of Symvess, as demonstrated in two previous trials.

In response to the New York Times’ reliance on Dr. Lee as a primary source, Niklason clarified that he was not part of the formal review team for Symvess at the FDA. She also pointed out that Dr. Lee had resigned from the FDA in late September, prior to the FDA’s decision to approve Symvess.

Niklason also took issue with the New York Times’ coverage on other points, such as the claim that ruptures of synthetic grafts are unheard of and that shrapnel wounds are not typically seen on the battlefield. She refuted these claims, citing her own experience and data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

Niklason reaffirmed Humacyte’s commitment to safety and the effectiveness of its product. In a civilian trauma trial of Symvess, which treated patients with severe injuries, the results were excellent, with an independent safety review committee attributing any instances of amputation or patient death to the underlying injuries and complications, not Symvess.

Niklason concluded by highlighting that over the past 12 years, Humacyte’s engineered vessels have treated more than 600 patients in 9 separate clinical studies, none of which have been halted for safety concerns. She expressed optimism for the future of Symvess in treating trauma patients in the United States.

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