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Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15

 

  • Lyme disease is the fastest growing vector-borne infectious disease in the United States, according to the CDC;
  •  Currently, there is no vaccine available to protect humans against Lyme disease and VLA15 is the only candidate in clinical development; 
  • Valneva recently completed Phase I subject enrollment and expects to announce first results in Q1 2018; 
  • The Company aims to accelerate VLA15’s development and plans to initiate a Phase II trial in Q1 2018;
  • Fast track designation may offer a faster way to market approval through frequent interactions with the FDA.

 

 

Lyon (France), July 24, 2017 – Valneva SE (“Valneva” or “the Company”), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its Lyme disease vaccine candidate VLA15.

 

 

Read the press release