Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal Nocturnal Hemoglobinuria

 Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal Nocturnal Hemoglobinuria

Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal Nocturnal Hemoglobinuria

Shots:

  • The FDA’s BT designation is based on safety & efficacy data of ongoing P-II study assessing Danicopan in combination with C5 mAb for patients with paroxysmal nocturnal hemoglobinuria (PNH) who are suboptimal responders to C5 inhibitor monothx. with its expected results in Q4’19
  •  The US FDA’s BT designation expedite the development and review of drugs for serious or life-threatening conditions
  • The Danicopan is an orally active Factor D inhibitor, act by limiting both intravascular and extravascular hemolysis and has received FDA’s ODD in 2017 with its expected onset of P-III study in H1’2020

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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