RE:FYI
Info only - picked up off another board:
- breakthrough therapy designation is requested by the drug company. If a sponsor has not yet requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if (1) after reviewing submitted data and information the agency thinks the drug development program MAY meet the criteria for breakthrough therapy designation and (2) the remaining drug development program can benefit from a BT designation.
ideally, a breakthrough therapy designation request should be received by FDA no later than the end of phase 2 meetings if any of the features of the designation are to be obtained. Because the primary intent of breakthrough therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that breakthrough therapy designation request will be made after the submission of an original BOA. FDA will respond to breakthrough therapy designation request within 60 days of receipt of the request.
And once a drug is designated as a breakthrough therapy, investigational drugs receive intensive FDA guidance on an efficient drug development program, and organizational commitment to expedite the FDA development and review, and potential eligibility, based on supporting clinical data.