Cibinqo impending approval to shake up EU atopic dermatitis market with heightened competition, says GlobalData

Pfizer’s Cibinqo (abrocitinib) is likely to be approved by the EU for the treatment of ‘moderate to severe’ atopic dermatitis (AD) by this year-end ensuing a positive European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) opinion on 15 October 2021. Following the approval of Lilly/Incyte’s Olumiant (baricitinib), and more recently AbbVie’s Rinvoq (upadacitinib), competition is likely to heighten once Cibinqo becomes available in the market, says GlobalData, a leading data and analytics company.

Ramla Salad, Pharma Analyst at GlobalData, comments: “Cibinqo is on track to become the third oral JAK inhibitor approved for this indication in the EU, arriving soon after Lilly’s Olumiant and AbbVie’s Rinvoq, which were approved in September 2020 and August 2021, respectively.

“While Olumiant and Rinvoq clearly have a first-mover advantage over Cibinqo, Pfizer’s product may still retain the competitive edge, at least over Olumiant, based on data from its Phase IIIb head-to-head (H2H) JADE DARE study (NCT04345367), demonstrating superior efficacy to Sanofi’s Dupixent (dupilumab).”

Both Olumiant and Rinvoq have already been approved in the EU for other autoimmune conditions, since February 2017 and December 2019, respectively.

Ms. Salad continues: “This has perhaps supported their entry into the AD market as there was already some real-world use. Once approved, AD will be the first indication for Cibinqo, so Pfizer will need to raise awareness of its JAK 1 inhibitor by educating patients and physicians to increase familiarity.

“AbbVie and Pfizer both conducted H2H studies (JADE DARE and HEADS-UP, respectively) on their JAK 1 inhibitors, Rinvoq and Cibinqo, against Dupixent, which reaped superior safety and efficacy data. Both companies presented top-line data at the European Academy of Dermatology and Venereology (EADV) 2021, that demonstrated the inhibitors were superior to Dupixent, especially when looking at stringent endpoints such as the Eczema Area and Severity Index (EASI) 90 or EASI 100.

“However, AbbVie holds the edge here with an EASI 100 readout, whereas Pfizer did not present any comparisons using EASI 100 as it was not a secondary outcome, but instead focused on EASI 75 and EASI 90. This difference could bolster confidence in Rinvoq as it also showed superiority in EASI 100 as well as EASI 75 and EASI 90.”

However, it remains to be seen if Lilly/Incyte will initiate an active comparator ‘Olumiant versus Dupixent’ study to best position the drug against imminent competition from Rinvoq and Cibinqo, despite its first-to-market advantage in the EU. It is possible that Pfizer may use H2H data in future messaging to support claims about safety and efficacy once Cibinqo reaches the market.

Given that Olumiant has not shown such data, key opinion leaders (KOLs) interviewed by GlobalData mentioned they would perhaps prefer to use Cibinqo or Rinvoq over Olumiant, even though the latter received the first approval for AD. GlobalData expects that Cibinqo will be approved by year-end in the EU for the treatment of moderate to severe AD but may face challenges due to increased competition in the AD space.

More Media