Thirteen of the nineteen investigational drugs with PDUFA Dates prior to the end of the year are due for approval during the third quarter. Twelve different drug classes are represented in the Q3 group. Four of the Q3 potential approvals have been fast tracked while two have been designated orphan drugs by the FDA. Five of the drugs are Breakthrough Therapies and one is a Qualified Infectious Disease Product. Two of the third quarter projected approvals had their BLAs approved during Q1, and three of the Q3 projected approvals had their NDAs approved during Q1.
During the first quarter FDA approved six new drugs. There were four rejections and seven changes in priority designations. Additionally, one drug was put on a hold and three others were delayed. Stay tuned for a complete first half 2019 approvals review.
Among the delays was Karyopharm Therapeutics’ selinexor which now has a 6 July 2019 PDUFA Date and Nektar’s NKTR-181 with a current PDUFA Date of 29 August 2019.
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