European drug regulators have been busy this week – opting to approve several medicines from companies like AbbVie, Pfizer & BioNTech and Incyte across dermatological, infectious disease and immunological indications.
First up is AbbVie, which has secured the greenlight for its blockbuster Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib) from the European Commission (EC) in both non-segmental vitiligo (NSV) and alopecia areata – notching another two indications onto the drug’s growing list.
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This makes the EC the first regulator to grant Rinvoq market clearance for severe alopecia areata, which impacts around 160 million people worldwide, as per the National Alopecia Areata Foundation. The agency approved Rinvoq for use in patients aged 12 and over based on the results of the ongoing Phase III UP-AA study (NCT06012240), in which the JAK inhibitor prompted significantly more patients to achieve scalp hair coverage of 80% or more over placebo.
Following its debut on the European alopecia areata market, Rinvoq will have to compete for a share of the market dominated by fellow JAK inhibitor, Eli Lilly’s Olumiant (baricitinib) and Pfizer’s kinase blocker, Litfulo (ritlecitinib). The EC recommends both drugs for use in patients aged 12 years and up with severe alopecia areata.
Meanwhile, Rinvoq netted an approval in NSV based on the outcomes of the Phase III Viti-Up trial (NCT06118411), in which the JAK inhibitor significantly improved re-pigmentation over placebo on both the body and face of treated patients at week 48.
With Rinvoq’s European NSV approval in the bag, AbbVie has become the first company to successfully get a systemic medication to market in this indication – offering European patients with this condition a first treatment option and representing another growth opportunity for the drug.
Currently, a sales and consensus forecast from GlobalData estimates that Rinvoq will surpass the mega-blockbuster milestone in 2026, with sales continuing to balloon to over $17bn in 2032.
Pfizer and BioNTech’s Covid vaccine update gets the go-ahead
Over in the world of infectious disease, Pfizer and partner, BioNTech have secured an EC approval for the updated 2026-2027 formulation of their co-developed mRNA-based Covid-19 vaccine, Comirnaty.
The jab, which is now approved for use in people aged six months or older, has been specifically adapted based on recommendations from the European Medicines Agency’s (EMA) Emergency Task Force, which recommended that Comirnaty be altered to target the XFG variant, which the agency says will provide the “best protection against Covid-19 caused by JN.1 omicron subvariants”.
Comirnaty was approved based on data from clinical, real-world and non-clinical studies that highlight the vaccine’s safety, efficacy and capacity to generate strong immune responses in Covid-19 strains currently circulating around Europe.
Following this regulatory approval, Pfizer and BioNTech have already got to work manufacturing the XFG-adapted version of this vaccine, to ensure that the supply is ready as the respiratory disease season draws near.
The pair will also vie for the updated jab’s approval on a global scale, with submissions made across the globe.
This approval comes as scepticism towards mRNA-based vaccines, continues to rise across America, with US Secretary of Health and Human Services (HHS), Robert F Kennedy Jr opting to cut funding to mRNA vaccine development initiatives back in August 2025 – leading to a sharp decline in venture financing for mRNA-based innovator vaccines.
Incyte’s topical JAK inhibitor gets the nod in eczema
AbbVie is not the only company to secure the EC go-ahead for a JAK inhibitor this week, as Incyte has netted an approval for its topical therapy, Opzelura (ruxolitinib) in adults with moderate atopic dermatitis (AD) who have either not responded or are ineligible for topical corticosteroids or topical calcineurin inhibitors.
This marketing authorisation makes Opzelura the first steroid-free topical JAK inhibitor to secure an approval in the EU, adding another treatment option to the AD therapeutic arsenal.
Opzelura got the EC’s blessing based on the results of the Phase IIIb TRuE-AD4 study (NCT06238817), which found that the drug significantly and durably reduced clinical signs and symptoms of AD, while offering quality of life improvements. Data from the Phase III TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) studies also supported Incyte’s AD submission for Opzelura.
Opzelura now has two indications to its name in Europe, with its first approval in NSV dating back to 2023.
The drug, which GlobalData forecasts will reach a blockbuster status in 2028, will now enter a market that a GlobalData report estimates will be worth $26.2bn in 2033.
GlobalData is the parent company of Pharmaceutical Technology.
