Tags : Breakthrough Therapy Designation

Eli Lilly and Incyte’s Olumiant (baricitinib) Receives the US FDA’s

Shots: The FDA’s BT designation is based on P-II results of P-II/III BRAVE-AA1 study assessing baricitinib vs PBO in patients with AA The P-II portion of the BRAVE-AA1 study demonstrated no new safety signals with no SAEs @36wks. Additionally, P-III portion of BRAVE-AA1 & P-III BRAVE-AA2 study, are currently evaluating baricitinib (2mg/4mg) vs PBO in […]Read More

Chugai’s Nemolizumab Receives the US FDA’s Breakthrough Therapy Designation to

Shots: Nemolizumab is a novel therapy targeting IL-31 receptor A developed utilizing Chugai’s antibody engineering technology ACT-Ig. The 8th BT designation is granted to the Chugai based on P-II clinical study conducted by Galderma and the results were presented at EADV 2019 The BT designation is granted to serious or life-threatening disease therapies demonstrate a […]Read More

Janssen’s Niraparib Receives the US FDA’s Breakthrough Therapy Designation for

Shots: The breakthrough designation is based on P-II GALAHAD study assessing Niraparib in adult patients with BRCA1/2 gene-mCRPC and DNA-repair gene defects (DRD) prior treated with androgen-receptor targeting therapies and docetaxel The FDA’s BT designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious […]Read More