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October 28, 2021

Competition is heating up as Pfizer’s Cibinqo receives positive CHMP opinion

The opinion means Cibinqo will become the third oral JAK inhibitor approved for this indication in the EU.

By GlobalData Healthcare

On October 15, Pfizer’s Cibinqo (abrocitinib) received a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for the use of all three doses (50, 100, and 200mg) of the drug in the treatment of adults with moderate to severe atopic dermatitis (AD).

The positive opinion was supported by Cibinqo’s ability to improve the skin condition, as assessed in Pfizer’s extensive JADE clinical program. With this opinion, Cibinqo is on track to become the third oral JAK inhibitor approved for this indication in the EU, arriving soon after Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib), 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 a 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).

Given the average timeframe between a CHMP positive opinion and European Commission (EC) approval, Cibinqo is on track to gain approval in December 2021, four months after Rinvoq and 15 months after Olumiant.

Depending on pricing negotiations, access for patients in a clinical setting could be dragged out further. Both Olumiant and Rinvoq have already been approved in the EU for other autoimmune conditions, since February 2017 and December 2019, respectively. This has likely 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. It remains to be seen if Lilly/Incyte will initiate an active comparator study of Olumiant versus Dupixent in order to best position the drug against imminent competition from Rinvoq and Cibinqo, despite its first-to-market advantage in the EU.

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The H2H trial data versus Dupixent shows that Cibinqo and Rinvoq are faster than Dupixent for targeting/managing itch, demonstrating benefit in as little as one week for Rinvoq and two weeks for Cibinqo. Given that Olumiant has not shown

such data, key opinion leaders (KOLs) interviewed by GlobalData mentioned they would likely prefer to use Cibinqo or Rinvoq over Olumiant, even though the latter received the first approval for AD.

With Cibinqo’s looming EU approval, competition is expected to heighten among the oral JAK inhibitors, but even more so for Olumiant as Lilly/Incyte have yet to conduct an H2H study against Dupixent. AbbVie’s Rinvoq has been approved more recently than Cibinqo, and it also demonstrated positive H2H results, so the main competition will likely be between the JAK 1 inhibitors. 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.

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