The European Commission has approved Rinvoq (upadacitinib), AbbVie’s daily pill already used for arthritis, eczema and gut diseases, for people aged 12 and over with severe alopecia areata, an immune disease that makes hair fall out. AbbVie announced the decision on 29 July 2026. Our previous article covered the two large trials behind it. This one covers the regulatory decision those trials supported, what the approval does and does not settle, and what comes next.
What changed
Before this decision, Rinvoq was not approved for alopecia areata anywhere in the European Union2. On 29 June 2026, the European Medicines Agency’s expert committee on human medicines, known as the CHMP, recommended approval and said a final decision from the European Commission was expected in the coming months2. A month later, AbbVie said that final approval had been granted.
The approval covers adults and adolescents aged 12 and over with severe alopecia areata, taking one pill a day at either 15 mg or 30 mg. When AbbVie described an earlier European Commission approval of Rinvoq, for eczema in 2021, it said such a marketing authorisation applies in all EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland3.
Alopecia areata is an autoimmune disease: the immune system attacks hair follicles4. It can show up as sudden round bald patches on the scalp or as complete loss of all body hair, including eyebrows and eyelashes2. AbbVie notes it is often treated as a cosmetic problem despite being an immune disease, which can lead to stigma2. M2 Pharma, reporting the approval, cited population research suggesting patients face up to a 40% higher risk of new depression and anxiety.
The trial evidence behind the decision
Rinvoq belongs to a group of drugs called JAK inhibitors, which block signals inside immune cells2. The decision rests on AbbVie’s UP-AA program: two matched trials run under one plan, each randomized (people assigned to groups by chance), placebo-controlled (compared with a dummy pill) and double-blind (neither patients nor doctors knew who got what)2. Together they enrolled 1,399 people aged 12 to 64 with severe alopecia areata at 248 sites worldwide.
People entered the trials with very little hair. Their average score on the SALT scale, which measures the share of scalp without hair, was 83.8, meaning about 16% of the scalp had hair5. For the first 24 weeks, participants took 15 mg of Rinvoq, 30 mg, or a dummy pill2.
The main goal was a SALT score of 20 or lower at week 24, meaning at least 80% of the scalp covered with hair. Both doses met that goal in both trials, with significantly more people reaching it than on the dummy pill2. Results reported by the Dermatology Education Foundation give a stricter measure: 36% of people on 15 mg and 47.1% on 30 mg had 90% or more of their scalp covered at week 24, compared with 1.4% on placebo5.
Both doses also met goals for regrowth of eyebrows and eyelashes, and for complete scalp regrowth (a SALT score of 0) at week 245. AbbVie says Rinvoq is the first JAK inhibitor to meet that complete-regrowth goal at 24 weeks2.
Side effects seen so far
In the 24-week placebo-controlled period, AbbVie said the safety profile of both doses was generally consistent with what has been seen in Rinvoq’s other approved uses2. The reported details:
- Serious side effects occurred in 1.4% of people on 15 mg and 2.8% on 30 mg, and in no one on the dummy pill5.
- 0.7% on 15 mg and 1.4% on 30 mg stopped treatment because of side effects; no one on placebo did5.
- The most common side effects were acne, colds and upper respiratory infections5.
- Serious infections were reported in 0.7% on 15 mg and 1.0% on 30 mg5.
- No major heart events, cancers or deaths were reported; one blood clot in a vein was reported in a person on 15 mg who had several risk factors5.
For comparison, in Rinvoq’s earlier eczema trials, the most common side effects were upper respiratory infection, acne, cold sores, headache and a raised muscle enzyme in blood tests, and serious infections affected fewer than 1% of people3.
What the approval does not show yet
An approval is a regulator’s judgment on the data so far, not new data. The published efficacy and safety figures cover the first 24 weeks5. The program continues well beyond that: people who started on Rinvoq keep taking the same dose for another 28 weeks, for 52 weeks in all, and those who finish can join an extension study for up to 108 more weeks2. The trial registry lists adverse events over about 164 weeks as a main outcome, and the program’s primary completion date is April 20304.
That means several questions remain open in the sources available: how many people keep their regrown hair over a year or longer, what happens if the pill is stopped, and whether rarer side effects appear with years of use. The trials also included only people aged 12 to 64, so they say little about older patients.
Who is behind it
AbbVie discovered and developed Rinvoq and sponsors the alopecia trials24. The efficacy and safety figures come from the company’s own program, and the main news releases about the trial results and the approval came from AbbVie. Independent coverage of the approval, such as M2 Pharma’s, relays the company’s announcement.
Alopecia areata is the latest in a series of EU approvals for Rinvoq. By April 2023, Crohn’s disease was its seventh approved use in the EU6. M2 Pharma lists its current EU approvals as including eczema, several forms of arthritis, ulcerative colitis, Crohn’s disease, giant cell arteritis and non-segmental vitiligo. AbbVie’s June statement had listed vitiligo among diseases still being studied in late-stage trials2, so that approval appears to have come in the weeks between the two reports.
AbbVie’s own materials also note that the relevance of blocking specific JAK enzymes to how well the drug works, and to its safety, is not currently known2.
What to watch next
- The US decision. Rinvoq’s use in alopecia areata remains under review by the US Food and Drug Administration.
- One-year and longer results. Data from the 52-week part of the trials and from the extension study of up to 108 weeks will show whether regrowth holds and how the safety picture develops2.
- A larger program. The registry now describes a fourth study and an estimated 1,500 participants at about 280 sites, with treatment for up to 160 weeks4.
- Other diseases. Upadacitinib is also in late-stage trials for hidradenitis suppurativa, Takayasu arteritis and lupus.
Biohack will update this thread when the FDA rules or when longer-term results are published.
