Rinvoq and Cibinqo Janus kinase (JAK) inhibitors approved by FDA with boxed warnings and restrictive labelling, says GlobalData

AbbVie’s Rinvoq (upadacitinib) and Pfizer’s Cibinqo (abrocitinib) have been approved by the FDA for the treatment of refractory atopic dermatitis (AD), despite ongoing safety concerns and multiple delays.

Both AbbVie and Pfizer’s products assets are the first small molecules, specifically Janus kinase (JAK)-1 inhibitors, to be approved in the US, as treatment options for patients who are not responding to already available therapies. Therefore, competition within the class is expected to heighten once they both become available on the market, says GlobalData, a leading data and analytics company.

Ramla Salad, Pharma Analyst at GlobalData, comments: “Although, it is an exciting breakthrough for the AD space these agents will not be used in the first line as the label says they should be used once all other therapy options are exhausted, including biologics, or when the use of certain therapies is inadvisable. Thus placing them behind competitor biologics such as Sanofi/Regeneron’s Dupixent (dupilumab) and LEO Pharma’s Adbry (tralokinumab), the latter of which was FDA approved in late December 2021.”

The FDA did approve all doses for Rinvoq (15mg and 30mg) and Cibinqo (50mg, 100mg, and 200mg), dismissing initial fears that only the lower doses would gain approval. Patients will have to be closely monitored as the FDA has given specific guidelines for each dose, titrating up the dosage as needed. While Cibinqo’s recommended starting dosage is 100mg, the 50mg dosage was approved for patients with moderate renal impairment, those receiving cytochrome P450 inhibitors, or those who are known or suspected to be poor metabolizers of CYP2C19 (an enzyme that breaks down several drug classes), which is determined by genetic variation. Patients who fit these special considerations may increase their dosage up to 100mg if they do not respond adequately to 50mg.

These FDA approvals have solidified a future for the JAK inhibitor class in the AD market, while also providing hope for patients who are not responding to already available therapies.

KOLs interviewed by GlobalData stated that although JAK inhibitors such as Rinvoq and Cibinqo have a fast onset of action, their safety profiles raise concerns about long term use. GlobalData anticipates that their initial uptake will be slow, but that it may improve with long-term safety and efficacy data.”

Salad adds: “Pfizer may have a unique advantage due to the specific populations Cibinqo is targeting and they will likely face little competition in these patients since competitors have not targeted these niche populations. Rinvoq has a different advantage to Cibinqo as it is approved for use in both adults and adolescents (patients ages 12 years and older) whilst Cibinqo is just approved for adult use. Thus, Rinvoq is expected to have a larger market share due to its anticipated patient reach.”

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