A clinical study found that Rinvoq (ingredient upadacitinib), made by U.S.-based AbbVie and used to treat inflammatory diseases such as atopic dermatitis and arthritis, helped hair regrow in patients with severe alopecia areata. With the possibility raised that a treatment for alopecia areata could be approved, Korean drugmakers developing upadacitinib generics are also taking notice.
According to the industry on the 3rd, the international journal JAMA Dermatology published phase 3 trial results of upadacitinib conducted in 1,399 patients with severe alopecia areata.
Researchers assigned participants to a 15 mg upadacitinib group, a 30 mg group, or a placebo group, and administered the drug once daily. At the start of the trial, participants had, on average, lost 83.9% of scalp hair, indicating severe alopecia areata.
After 24 weeks of treatment, the proportion of patients with at least 80% of the scalp covered with hair was 45.2% in the 15 mg group and 55.0% in the 30 mg group in the first clinical trial. In the second clinical trial, 44.6% and 54.3%, respectively, met the same threshold.
By contrast, in the placebo group, 1.5% of patients in the first trial and 3.4% in the second had at least 80% scalp coverage with hair.
Rinvoq is used to treat a range of inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Its active ingredient, upadacitinib, is a Janus kinase (JAK) inhibitor that blocks signaling involved in inflammatory immune responses.
Alopecia areata is an autoimmune disease in which the immune system mistakenly attacks hair follicles, causing hair loss. The researchers assessed that upadacitinib suppresses the immune response targeting hair follicles, helping hair regrow.
Upadacitinib is not yet approved as a treatment for alopecia areata. The clinical trial was supported by AbbVie, the developer of upadacitinib, and AbbVie also took part in the study design, data collection and analysis, and manuscript review. The researchers are conducting follow-up studies to assess long-term efficacy and safety.
If AbbVie expands the treatment scope to alopecia areata, it could become a new variable in the domestic generic market. That is because additional use patents may be filed to protect new treatment indications or methods of use in specific patient groups.
Currently, Chong Kun Dang pharmaceutical(185750), Daewoong Pharmaceutical(069620), GC녹십자, Ildong Pharmaceutical(249420), and Huons(243070) are challenging AbbVie's domestic patents as they prepare to develop Rinvoq generics.
These drugmakers filed for a negative scope confirmation trial with the Intellectual Property Trial and Appeal Board regarding Rinvoq's salt and polymorph patents and received decisions in their favor. A salt patent protects technology that combines a drug's active ingredient with another substance to create a more stable medicine. A polymorph patent protects technology that alters the molecular structure of the same ingredient to improve a drug's stability or storability.
Korean drugmakers won findings that the upadacitinib generics they are developing do not infringe AbbVie's patents in question. As a result, without waiting until the related patents expire in 2036, they have secured a legal basis to launch generics in Korea—used for chronic conditions such as arthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease—if certain requirements are met.
However, even after generics are launched, if separate use patents for hair-loss diseases such as severe alopecia areata remain valid, prescriptions or sales targeting those indications could be restricted. In other words, whether upadacitinib's treatment scope is expanded and AbbVie's resulting patent strategy could affect when and how broadly domestic generic makers enter the market.
Rinvoq is seen as AbbVie's next-generation blockbuster to follow its flagship blockbuster Humira. It has filled the sales gap left by Humira's patent expiry and has become a key growth driver for AbbVie. Rinvoq is approved to treat the most indications—nine—among JAK inhibitors and holds the No. 1 global market share among drugs in the same class, including Xeljanz, Olumiant, and Cibinqo.
An industry official said, "Because Rinvoq is a core growth item for AbbVie, the company is unlikely to give up major patents easily," and added, "For Korean drugmakers to push ahead with generic launches, they need a strategy that closely reviews not only existing patents but also potential future use patents."