Merrimack Valley News

LOWELL, MA – On May 3, Congresswoman Lori Trahan (MA-03-D) and Congressman Dan Crenshaw (TX-02-R) sent a letter to the Food and Drug Administration (FDA) requesting information on the agency’s plan for authorizing new monoclonal antibodies and antiviral therapeutics.

The FDA recently deauthorized the last mAbs for COVID-19 and there is a lag in getting an updated version reauthorized. The letter to the agency asks for additional information on authorizing and approving updated COVID-19 therapeutics, inquires about the Administration’s Project Next Gen, and seeks feedback on a platform technology designation that could aid approval. 

"While the FDA has modernized its process in the past for influenza vaccines and pioneered an unprecedented public-private partnership through the multi-agency Operation Warp Speed for COVID vaccines, we fear it has not provided the same attention to other interventions," write Representatives Trahan and Crenshaw. "Our foremost concern is that new variants are developing faster than current FDA emergency use authorization (EUA) reviews can be completed – all despite the continued innovation to update drugs and biologics for a changing virus."

Patient groups across the country voiced their support for this letter.

"The Immune Deficiency Foundation urges the FDA to move forward with implementing the platform technology designation, as directed by Congress in the 2022 Omnibus, to help expedite the authorization and approval of effective treatments and prophylactic therapies, such as monoclonal antibody therapies, to address evolving COVID-19 variants," said Lynn Albizo, Vice President of Public Policy at the Immune Deficiency Foundation. "We applaud Representative Crenshaw and Trahan in leading the effort to ensure that those who are immunocompromised have the access to therapies that will protect them from serious illness."

“The COVID-19 public health emergency declaration expires May 11, but the virus and its evolving variants still pose a risk to millions of people in the United States, especially vulnerable populations including those who live with chronic kidney disease, end-stage renal disease and kidney transplant recipients," said LaVarne Burton, President and CEO of the American Kidney Fund. "It’s critically important to have approved therapies to help protect those who are immunocompromised against COVID-19-related hospitalization, complications or death.” 

“We at Invivyd are committed to developing antibody solutions for patients in need, and we are grateful for the leadership that Rep. Crenshaw and Rep. Trahan have shown in ensuring that COVID-19 remains a focus for federal agencies until the national medicine cabinet has therapeutic options for every patient and every variant," said David Hering, CEO of Invivyd. 

Read the full letter HERE.

Original source can be found here.