Date: 2018-09-05
Type of information: Granting of the Breakthrough Therapy status
Product name: PF-06651600
Compound:
Therapeutic area: Autoimmune diseases - Dermatological diseases
Action mechanism:
- janus kinase inhibitor/JAK3 inhibitor. PF-06651600, a newly discovered potent JAK3-selective inhibitor, is highly efficacious at inhibiting ?c cytokine signaling, which is dependent on both JAK1 and JAK3. (Design of a Janus Kinase 3 (JAK3) Specific Inhibitor 1-((2S,5R)-5-((7H-Pyrrolo[2,3-d]pyrimidin-4-yl)amino)-2-methylpiperidin-1-yl)prop-2-en-1-one (PF-06651600) Allowing for the Interrogation of JAK3 Signaling in Humans. J Med Chem. 2017 Mar 9;60(5):1971-1993. doi: 10.1021/acs.jmedchem.6b01694. Epub 2017 Feb 16.)
Company: Pfizer (USA - NY)
Disease: alopecia areata
Latest news:
- • On September 5, 2018, Pfizer announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the FDA for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body. The Breakthrough Therapy designation for alopecia areata was supported by positive results from a Phase 2 study, which will be presented during the late-breaking news session at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris on September 15, 2018. Pfizer is also working with the European Medicines Agency (EMA) on the clinical development program for PF-06651600.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
