Lea Eslava-Kim, PharmD

Most Recent Articles by Lea Eslava-Kim, PharmD

Tezacaftor/Ivacaftor Gets Priority Review for Cystic Fibrosis

By Aug 25, 2017

The FDA has granted Priority Review to the New Drug Application (NDA) of tezacaftor/ivacaftor (Vertex) for the treatment of patients ≥12yrs old with cystic fibrosis (CF) who have two copies of the F508del mutation or one F508del mutation and one residual function mutation.

BLA for Novel Hemophilia A Therapy Granted Priority Review

By Aug 24, 2017

The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) of emicizumab (Genentech) for the prophylactic treatment of hemophilia A in adults, adolescents and children with factor VIII inhibitors.

Novel Reversal Agent for Factor Xa Inhibitors Under FDA Review

By Aug 17, 2017

The FDA has accepted for review the BLA resubmission for AndexXa (andexanet alfa; Portola) for the reversal of the anticoagulant effects of Factor Xa inhibitors in patients experiencing uncontrolled or life-threatening bleeding.

Biologic for Migraine Prevention Submitted to FDA

By May 18, 2017

Amgen announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for erenumab for the prevention of migraines.

Neuroactive Steroid Gets Fast Tracked for Major Depressive Disorder

By May 18, 2017

The Food and Drug Administration (FDA) has granted Fast Track designation to SAGE-217 (Sage Therapeutics) for the potential treatment of major depressive disorder (MDD).

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