LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

August 5, 2020 Auto Bot Fast Track Designation, FDA, Latest, Pharma, receives, regulatory, Treat 0

Shots:

  • The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE
  • The FDA’s FT designation facilitates the development and expedites the regulatory review of drugs to treat serious conditions and demonstrate the potential to address an unmet medical need
  • Delgocitinib (bid, topical formulation) acts by inhibiting the activation of the JAK-STAT pathway, currently being evaluated in two P-IIb studies for mild-to-severe CHE & AD. The company plans to submit the results of P-IIb CHE study in late 2020

Click here ­to­ read full press release/ article | Ref: LEO Pharma | Image: LEO Pharma