In a press release on September 5, Pfizer (PFE) announced that the FDA had granted a breakthrough therapy designation to its investigational drug PF-06651600 for the treatment of patients with alopecia areata based on the data from the company’s Phase 2 study.
The chart above shows key details for PF-06651600.
PF-06651600, an investigational drug, is an orally administered small molecule that inhibits the Janus kinase 3 gene. The drug is under investigation for its use in the treatment of alopecia areata, rheumatoid arthritis, ulcerative colitis, and Crohn’s disease.
About the designation
The FDA granted PF-06651600 a breakthrough therapy designation based on the data from Pfizer’s Phase 2 study. The results from the study will be presented at the 27th European Academy of Dermatology and Venereology Congress in Paris on September 15 during the late-breaking news session.
At present, there are no treatments approved by the FDA for the treatment of alopecia areata. Alopecia areata is an autoimmune disease in which immune cells attack healthy hair follicles, causing hair loss in round patches. The mean age for the disease’s onset is between 25 and 35 years, but the disease also affects children and adolescents irrespective of sex or ethnicity.
Apart from PF-06651600, Pfizer has other kinase inhibitors undergoing trials for various indications. These include PF-04965842, PF-06700841, PF-06650833, and PF-06826647.
Following the news of the breakthrough therapy designation, Pfizer stock rose ~1.3% to $41.85 on September 5 compared to its previous day’s close of $41.29.
The Health Care Select Sector SPDR ETF (XLV) holds 6.8% of its total investments in Pfizer, 2.8% in Eli Lilly and Company (LLY), 2.8% in Bristol-Myers Squibb (BMY), and 10.1% in Johnson & Johnson (JNJ).