Boehringer Ingelheim’s Ofev (nintedanib) Receives the US FDA’s Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype

Boehringer Ingelheim Signs a Clinical Research Agreement with Amal for the Evaluation of Combination Therapy to Treat Stage IV Colorectal Cancer

Shots:

  • The BT designation is based on P-III INBUILD study results assessing OFEV vs PBO in patients with chronic fibrosing interstitial lung disease (ILDs) with signs of progression for 52 wks. resulted in slowed lung function decline by 57% in overall population
  • The FDA’ BT designation is established to accelerate the development and review of drugs for serious or life-threatening diseases where preliminary clinical evidence indicate that the therapy may demonstrate substantial improvement over existing therapies
  • Ofev (nintedanib) is a tyrosine kinase inhibitor approved in 70+ countries including the US, EU and Japan for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) and has also received the US FDA’s BT designation for IPF in July 2014  

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